Latest news with #FDAapproval
Forbes
4 days ago
- Business
- Forbes
Is SMMT Stock A Buy After Its Recent Plunge?
POLAND - 2025/01/09: In this photo illustration, the Summit Therapeutics company logo is seen ... More displayed on a smartphone screen. (Photo Illustration by Piotr Swat/SOPA Images/LightRocket via Getty Images) Summit Therapeutics (NASDAQ: SMMT) experienced a significant 30% decrease in its stock on Friday, May 30th, closing at $18. This sudden decline came even though the stock had doubled within the past year, driven by favorable updates regarding its lung cancer medication, ivonescimab. The recent drop was caused by a combination of trial outcomes. On a positive note, ivonescimab, when used alongside chemotherapy, reduced the risk of disease progression or mortality by 48%. Furthermore, the company detected no major differences between Asian and Western patient demographics, which holds great importance for future research. Nevertheless, the trial fell short of achieving the 'statistically significant' criteria for overall survival – which the FDA requires for approval. This understandably caused investors to react strongly. However, upon reflection, these results aren't as negative as the market perceived. In fact, we believe this actually brings Summit closer to obtaining FDA approval for ivonescimab since it demonstrates a reduced risk of disease progression and efficacy outside of Asia. Separately, take a look at – Buy, Sell, or Hold HIMS Stock? It's essential to keep in mind that Summit has yet to launch any commercial products, and ivonescimab has the potential to be a significant revenue generator. For biotech firms without market-ready products, their value hinges on the potential of their pipeline. The company has been depleting its resources, reporting net operating losses of $226 million last year and $610 million the year before. Despite the drop on Friday, we believe Summit remains worth considering. Naturally, there are risks involved. Any negative developments regarding its drug pipeline could severely impact the stock – the reaction on Friday clearly demonstrated its sensitivity to setbacks. The stock also has a history of performing poorly during market declines, evidenced by its staggering 94% drop during the 2022 inflation crisis compared to a 25% decline in the S&P 500, and its 78% decrease during the 2020 COVID-19 market correction versus a 34% drop in the S&P 500. Considering the latest results of ivonescimab, Summit Therapeutics could present a promising turnaround opportunity for investors willing to assess the risks involved. However, with numerous other robust investment choices available at present, careful consideration is necessary to determine if SMMT is the right selection. Keep in mind that there is always a significant risk associated with investing in a single stock, or a small number of stocks. Consider Trefis High Quality (HQ) Portfolio which, consisting of 30 stocks, has a proven track record of significantly outperforming the S&P 500 over the previous four-year period. Why is that? In aggregate, HQ Portfolio stocks offered superior returns with reduced risk compared to the benchmark index; they exhibited less volatility, as indicated by HQ Portfolio performance metrics.
Yahoo
27-05-2025
- Business
- Yahoo
Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing STELARA® (ustekinumab) Injection
GUANGZHOU, China and LONDON, May 27, 2025 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. STARJEMZA® is Bio-Thera's third FDA approved product. Bio-Thera and Hikma entered into a license and commercialization agreement for STARJEMZA® in August 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Hikma is responsible for the commercialization of STARJEMZA® in the United States. "The approval of STARJEMZA® is another significant accomplishment for Bio-Thera, establishing Bio-Thera as a premier global biosimilar developer and manufacturer," said Shengfeng Li, CEO at Bio-Thera. "As our third FDA approved biosimilar, STARJEMZA® demonstrates Bio-Thera's commitment to developing more biosimilars, expanding patient access to important therapies." "This approval and our partnership with Bio-Thera enables us to strongly enter the U.S. biosimilar market, building on our well-established position as a top-three domestic provider of sterile injectable medicines to U.S. hospitals, healthcare providers, and patients," said Dr. Bill Larkins, President of Hikma Injectables. "Tapping into the robust ongoing growth of the U.S. biosimilar market is a priority for Hikma. We are eager to use our excellent U.S. commercial capabilities to launch this important product and provide it to the many patients who will benefit from using it." The FDA approval of STARJEMZA®, originally known as BAT2206, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera to the FDA. Extensive analytical characterization between STARJEMZA® and US and EU Stelara® was conducted on structural, physicochemical, and biological properties to support bio-similarity of STARJEMZA®. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of STARJEMZA® with both the US and EU Stelara® in healthy volunteers. A multicenter, randomized, double-blind, parallel-arm, phase III study compared STARJEMZA® with Stelara® for efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis. The totality of the evidence demonstrated that STARJEMZA® has similar efficacy, safety, immunogenicity, and quality as the reference product ustekinumab. About STARJEMZA® (ustekinumab-hmny) InjectionSTARJEMZA® is a biosimilar to Janssen's Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 subunit from binding to the IL-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation, CD4+ T-cell differentiation and following relative cytokines stimulated release. Abnormal regulation of IL-12 and IL-23 have been implicated as important contributors to chronic inflammation, including psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), and Ulcerative colitis (UC). Neutralizing human IL-12 and IL-23 by STARJEMZA® to prevent the relevant cell signaling in the Th1 or Th17 lineages can effectively block the pathologic processes of these immune disorders. About Bio-Thera SolutionsBio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® in the US, and BAT1806/TOFIDENCE™ (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US, a/k/a POBEVCY® in EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera). About Hikma Pharmaceuticals(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: Cautionary Note Regarding Forward-Looking StatementsThis news release contains certain forward-looking statements relating to STARJEMZA®/BAT2206 or the product pipelines in general of Bio-Thera Solutions and Hikma. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and Hikma and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions and Hikma undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1) STARJEMZA® is a registered trademark of Hikma Pharmaceuticals USA Inc.2) STELARA® is a registered trademark of Johnson and Johnson3) QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.4) BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd.5) TOFIDENCE™ is a trademark of Organon LLC6) AVZIVI® is a registered trademark of Sandoz7) POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Bio-Thera ContactsBio-Thera Solutions, Ltd.:Bert E. Thomas IV+1.410.627.1734bethomas@ Hikma Pharmaceuticals PLCSusan Ringdal +44 (0)20 7399 2760/ +44 7776 477050EVP, Strategic Planning and Global Affairs Steven Weiss +1 732 788 8279US Communications Important Safety Information for STARJEMZA® (ustekinumab-hmny) Injection CONTRAINDICATIONS STARJEMZA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STARJEMZA. WARNINGS & PRECAUTIONS Infections - Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Avoid initiating treatment with STARJEMZA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STARJEMZA in patients with a chronic infection or a history of recurrent infection. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. Psoriatic arthritis: cholecystitis. Crohn's disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis. Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis. Theoretical Risk for Vulnerability to Particular Infections - Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. Pre-treatment Evaluation for Tuberculosis - Evaluate patients for tuberculosis infection prior to initiating treatment with STARJEMZA. Avoid administering STARJEMZA to patients with active tuberculosis infection. Malignancies - Ustekinumab products are immunosuppressants and may increase the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Hypersensitivity Reactions - Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STARJEMZA. Posterior Reversible Encephalopathy Syndrome (PRES) - Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products. Monitor all patients treated with STARJEMZA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STARJEMZA. Immunizations - Prior to initiating therapy with STARJEMZA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STARJEMZA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STARJEMZA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STARJEMZA because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of STARJEMZA may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia - Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. If diagnosis is confirmed, discontinue STARJEMZA and institute appropriate treatment. ADVERSE REACTIONS Serious adverse reactions associated with STARJEMZA include Infections, Malignancies, Hypersensitivity Reactions, Posterior Reversible Encephalopathy Syndrome (PRES), and Noninfectious Pneumonia. Immunogenicity - Approximately 6 to 12.4% of subjects treated with ustekinumab in plaque psoriasis and psoriatic arthritis clinical trials developed antibodies to ustekinumab, which were generally low-titer. In plaque psoriasis clinical trials, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab concentrations and reduced efficacy. In plaque psoriasis trials, the majority of subjects who were positive for antibodies to ustekinumab had neutralizing antibodies. In Crohn's disease and ulcerative colitis clinical trials, 2.9% and 4.6% of subjects, respectively, developed antibodies to ustekinumab when treated with ustekinumab for approximately one year. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen. Postmarketing Experience - The following adverse reactions have been reported during post-approval use of ustekinumab products: Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria). Infections and infestations: Lower respiratory tract infection (including opportunistic fungal infections and tuberculosis). Neurological disorders: Posterior Reversible Encephalopathy Syndrome (PRES). Respiratory, thoracic, and mediastinal disorders: Interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia. Skin reactions: Pustular psoriasis, erythrodermic psoriasis, hypersensitivity vasculitis. DRUG INTERACTIONS Concomitant Therapies - In plaque psoriasis trials the safety of ustekinumab products in combination with immunosuppressive agents or phototherapy has not been evaluated. In psoriatic arthritis trials, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn's disease and ulcerative colitis induction trials, immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn's disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of ustekinumab. CYP450 Substrates - The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of ustekinumab products, antagonists of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. A CYP-mediated drug interaction effect was not observed in subjects with Crohn's disease. Allergen Immunotherapy - Ustekinumab products have not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab products may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis. INDICATIONS AND USAGE STARJEMZA is indicated for the treatment of: adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. adults and pediatric patients 6 years of age and older with active psoriatic arthritis. adult patients with moderately to severely active Crohn's disease. adult patients with moderately to severely active ulcerative colitis. For additional Important Safety Information, please refer to the Package Insert for full prescribing information, available on To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800 FDA-1088 or For Product Inquiry call 1-877-845-0689. Manufactured by:Bio-Thera Solutions, Ltd.155 Yaotianhe Street, Huangpu District,Guangzhou, Guangdong, China 511356 Distributed By:Hikma Pharmaceuticals USA Heights, NJ 07922 USA HK-3278-v1 View original content to download multimedia: SOURCE Hikma Pharmaceuticals USA Inc. Sign in to access your portfolio
Associated Press
22-05-2025
- Business
- Associated Press
IBN Coverage: NRx Pharmaceuticals (NASDAQ: NRXP) to Present at Wall Street Conference on May 21
This article was published by IBN, a multifaceted communications organization engaged in connecting public companies to the investment community. LOS ANGELES, CA - May 21, 2025 ( NEWMEDIAWIRE ) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that Founder and CEO Dr. Jonathan Javitt will deliver a company update at the Wall Street Conference on May 21, 2025, in Palm Beach, Florida. NRx is one of six companies invited to present at the high-profile event, which is expected to draw more than 1,000 attendees representing over $1 trillion in investment capital. The presentation will highlight the company's progress toward FDA approval of NRX-100, a preservative-free intravenous ketamine formulation, as well as its strategic acquisition plans for HOPE clinics focused on treating suicidal depression, PTSD, and related conditions. To view the full press release, visit About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. For more information, please visit NOTE TO INVESTORS: IBN is a multifaceted financial news, content creation and publishing company utilized by both public and private companies to optimize investor awareness and recognition. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: The latest news and updates relating to NRXP are available in the company's newsroom at Forward Looking Statements Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading 'Risk Factors' discussed under the caption 'Item 1A. Risk Factors' in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption 'Item 1A. Risk Factors' in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law. About IBN IBN is a cutting-edge communications and digital engagement platform providing tailored Platform Solutions for select private and public companies. Over the course of 19+ years, IBN has introduced over 70 investor facing brands to the investment public and amassed a collective audience of millions of social media followers. These distinctive investor brands amplify recognition and reach as well as help fulfill the unique needs of our rapidly growing and diverse base of client-partners. IBN will continue to expand our branded network of influential properties as well as leverage the energy and experience of our team of professionals to best serve our clients. IBN's Platform Solutions provide access to: (1) our Dynamic Brand Portfolio (DBP) through 70+ investor facing brands; (2) article and editorial syndication to 5,000+ news outlets; (3) full-scale distribution to a growing Social Media Network (SMN) ; (4) a network of wire solutions via InvestorWire to effectively reach target markets and demographics; (5) Press Release Enhancement to ensure accuracy and impact; (6) a full array of corporate communications solutions; and (7) total news coverage solutions. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: Media Contact IBN Los Angeles, California 310.299.1717 Office [email protected] View the original release on
Fox News
12-05-2025
- Health
- Fox News
Three natural food dyes approved by FDA as RFK Jr. says industry is 'stepping up'
The U.S. Food & Drug Administration (FDA) has announced the approval of three natural-source colors in food items. Galdieria extract blue, butterfly pea flower extract and calcium phosphate can all be used now by any manufacturer for color-approved items. "I'm pleased to report that 'promises made' have been 'promises kept,'" FDA Commissioner Martin Makary said in a news release. Last month, the U.S. Department of Health and Human Services (HHS) and the FDA announced a ban on petroleum-based synthetic dyes within the nation's food supply, citing health concerns. "FDA staff have been moving quickly to expedite the publication of these decisions, underscoring our serious intent to transition away from petroleum-based dyes in the food supply and provide new colors from natural sources," Makary also said. Galdieria extract blue is a blue color derived from the unicellular red algae Galdieria sulphuraria. It is approved for nonalcoholic beverages and beverage bases, breakfast cereal coatings, candies, frozen desserts, frostings and other sweet selections, according to the news release. Butterfly pea flower extract, derived from water extraction of the dried flower petals of the butterfly pea plant, can achieve colors of blue, green and purple. The dye is already approved for various drinks but has been expanded to cereals, crackers, candies and different snacks. Calcium phosphate is a white color. It can be used now in chicken products and candies. In a Saturday appearance on "Fox & Friends Weekend," HHS Secretary Robert F. Kennedy Jr. detailed the announcement. He said the food industry "has really stepped up" and has been working together with federal agencies like the FDA. "The industry is coming to the table. They are talking to us. They are taking this seriously," he added. Vani Hari, Truvani founder and "Food Babe," told Fox News Digital on Monday that it's unprecedented to see the FDA moving so swiftly. "After this change, the industry will have no excuses not to convert their products to more natural sources," said Hari. "The industry will have no excuses not to convert their products to more natural sources." "Petroleum-based dyes are linked to a litany of health issues and it's time American food companies serve us the same safer ingredients they already use in other countries." Certified nutritionist and Realfoodology founder Courtney Swan told Fox News Digital, "We should have been using plant extracts all along." She added, "They exist in nature and don't have risks like the synthetic lab-made ones we've been using." Tyson Foods recently announced it intends to get rid of petroleum-based synthetic dyes from its products by the end of May, Fox News Digital reported.
Yahoo
11-05-2025
- Health
- Yahoo
FDA approves 3 natural food dyes
The Brief The FDA approved three natural food dyes this week amid its transition away from petroleum-based dyes in the food supply. The colors "will expand the palette of available colors from natural sources for manufacturers to safely use in food," the FDA said. The colors are Galdieria extract blue, butterfly pea flower extract and calcium phosphate. Amid its goal of eliminating certain artificial food dyes from the U.S. market, the Food and Drug Administration announced this week it has approved using color additives from three natural sources. The US Food and Drug Administration has approved three new color additives from natural sources. Dig deeper The three color additive petitions that were approved include Galdieria extract blue, butterfly pea flower extract and calcium phosphate. The backstory The FDA determines whether an additive is safe to use by considering the projected human dietary exposure to the color additive, the additive's toxicological data and other relevant information, such as published literature. Once the FDA approves a color additive petition, any manufacturer can use the coloring for the approved uses. What it is Galdieria extract blue is a blue color derived from a species of red algae known as Galdieria sulphuraria. How it will be used The FDA has approved the color additive for the following uses: Drinks including nonalcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages Breakfast cereal coatings Hard candy, soft candy and chewing gum Flavored frostings, ice cream and frozen dairy desserts Frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, and whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives) What it is Butterfly pea flower extract is produced through the water extraction of the dried flower petals of the butterfly pea plant, according to the FDA. It produces a blue color that can be used to create shades of bright blues, intense purples and natural greens. How it will be used The FDA has today approved the color additive for the following uses: Ready-to-eat cereals Crackers Snack mixes Hard pretzels Plain potato chips (restructured or baked) Plain corn chips, tortilla chips, and multigrain chips The coloring has already been approved for use in sport drinks, fruit drinks, fruit and vegetable juices, alcoholic beverages, dairy drinks, ready to drink teas, nutritional beverages, gums, candy, coated nuts, ice creams and yogurt. What it is Calcium phosphate is a mineral compound that can be used to create a white color. How it will be used The FDA has today approved the color additive for the following uses: Ready-to-eat chicken products White candy melts Doughnut sugar Sugar for coated candies Last month, health officials announced plans to begin phasing out eight petroleum-based artificial colors from the nation's food supply. READ MORE: FDA aims to eliminate petroleum-based synthetic dyes in food by end of 2026 Meanwhile So far this year, more than 20 states have introduced legislations that take aim at food chemicals, synthetic dyes and heavy metals, according to the Environmental Working Group. Additionally, the FDA banned Red 3 from foods earlier this year, with the order set to go into force in January 2027. RELATED: FDA bans Red 3 food dye, citing cancer risk What they're saying The FDA said this week that its approval of the three new natural color additives underscores their "serious intent to transition away from petroleum-based dyes in the food supply and provide new colors from natural sources." The three new approved colors "will expand the palette of available colors from natural sources for manufacturers to safely use in food," the FDA also said. The Source Information in this article was taken from a May 9, 2025, FDA news release on the approval of three food colors from natural sources. Background information on artificial food coloring was taken from previous FOX Television Station reportings. This story was reported from Detroit.
