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Newsweek
41 minutes ago
- Newsweek
Fruit Recall Given FDA's Highest Risk Warning
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. A recall of thousands of cans of fruit has been given the highest risk level by food inspectors, who are urgently warning consumers not to eat the product. More than 8,000 cans of Parashore Pear Slices in Juice, 15 oz. (425 g), distributed primarily through grocery stores in California, were recalled over fears the products could be contaminated with elevated lead and cadmium. The U.S. Food and Drug Administration (FDA) on August 4 designated the recall as a Class I, the highest of three warning levels, signifying a reasonable probability of serious adverse health consequences or death. The voluntary recall was issued by New York-based company W.W. Industrial Group on July 21. Newsweek reached out to the company via phone on July 23 for comment, but had not heard back at the time of publication. The recalled Parashore Pear Slices in Juice. The recalled Parashore Pear Slices in Juice. U.S. Food and Drug Administration Why It Matters This recall addresses serious concerns about heavy metal contamination in food products in the United States. Lead and cadmium are both toxic and can cause long-term health problems, especially for children. Metal toxicity depends upon the absorbed dose. Exposure to larger amounts of lead and cadmium can cause poisoning, the FDA warned in its July 23 alert announcing the recall. Symptoms can include abdominal pain, vomiting, lethargy, irritability, weakness, behavior or mood changes, delirium, seizures, and coma. "While these heavy metals can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age," it said. "However, infants, young children and the developing fetus can be affected by chronic exposure to amounts of heavy metals that may not result in obvious symptoms of lead poisoning. A child with heavy metal poisoning may not look or act sick," the FDA alert said. "Heavy metal poisoning in children can cause: learning disabilities, developmental delays, and lower IQ scores." What To Know The U.S. Food and Drug Administration (FDA) confirmed the recall involves Parashore Pear Slices in Juice, 15 oz. (425 g), with UPC#704817164237 and Lot 3700/01172 6122J, product date 02/19/2024, with a best-by date of 2/19/2027. More than 8,000 units were distributed, primarily to grocery outlets in California and also to other retail locations across the U.S., according to a July press release announcing the recall. Regulators issued a "Class I" recall on August 4, 2025, the FDA's most serious classification, used for situations where there is a "reasonable probability of serious adverse health consequences or death." Sampling and analysis carried out by the Maryland Department of Health, working as part of the FDA Laboratory Flexible Funding Model program, first identified the heavy metal contamination. Read more Sunscreen boss slams FDA recall for putting him "out of business" Sunscreen boss slams FDA recall for putting him "out of business" Both lead and cadmium are strictly regulated in food products by the FDA and other health agencies. Metal toxicity depends upon the absorbed dose. Acute lead exposure can cause loss of appetite, headache, hypertension, abdominal pain, renal dysfunction, fatigue, sleeplessness, arthritis, hallucinations and vertigo, according to a scientific review published by the National Institutes of Health in 2004. If cadmium is ingested in higher amounts, it can lead to stomach irritation and result in vomiting and diarrhea, the review said. No associated illness or health complaints had been reported at the time of the recall. The company is investigating the source of contamination to ensure corrective actions are taken and prevent further incidents, the FDA's July release said. What People Are Saying The U.S. Food and Drug Administration said in its public recall notice dated July 23, 2025: "Lead and cadmium are toxic substances present in our environment in small amounts and everyone is exposed to some of these heavy metals from daily actions such as inhaling dust, eating food, or drinking water. In general, the small exposure to lead within the U.S. population does not pose a significant public health concern." What Happens Next Consumers who purchased cans of Parashore Pear Slices in Juice with the specified lot number are advised to dispose of the product or return it to the place of purchase for a full refund. The FDA and W.W. Industrial Group have provided a hotline for further questions at 516-676-9188, available on weekdays from 10 a.m. to 4 p.m. ET.
Newsweek
41 minutes ago
- Newsweek
Canadian Cookie Recall in 20 US States Gets Risk Warning
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. The U.S. Food and Drug Administration (FDA) has issued a risk warning after hundreds of cases of cookies were recalled due to the possible presence of wood. The Class II warning was issued days after Canada-based Give and Go Prepared Foods Corp. recalled 803 cases of Favorite Day Bakery Frosted Sugar Cookies. The cookies were distributed by Target Corporation to stores in 20 U.S. states and Washington, D.C. Newsweek reached out to Target Corporation and Give and Go Prepared Foods Corp. via email for comment outside of working hours. Why It Matters The FDA has three classifications for recalls. A Class III is the least severe, whereas a Class I signifies a "situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." The FDA defines a Class II recall as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." Stock image of chocolate chip cookies unrelated to the recall. Stock image of chocolate chip cookies unrelated to the recall. James Nielsen/Houston Chronicle via AP/James Nielsen/Houston Chronicle via AP What To Know Give and Go Prepared Foods Corp., located in Etobicoke, Canada, voluntarily initiated a recall of the cookies on July 22, 2025. The product affected by the recall is the following: Favorite Day Bakery Frosted Sugar Cookies, 10 count, Net Wt 13.5 oz (383g). UPC - 85239-41250 3. Dist. By Target Corporation, Minneapolis, MN 55403. Product of Canada. The FDA health alert said the products, which contain 15 cookies per case, were distributed from centers in Connecticut, Maryland and Ohio. The affected cookies were sent to retail stores in Connecticut, the District of Columbia, Delaware, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Virginia and Vermont. The products were marked as lot 25195, with the "Best By" date applied by retailers upon removal from the freezer. The recall is ongoing, according to the FDA. What People Are Saying The FDA states on its website: "Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority." What Happens Next The recall remains ongoing. Neither Target Corporation nor Give and Go Prepared Foods Corp. has provided further information on the recall. There are no reports of any illnesses or injuries in relation to the recall.
Yahoo
an hour ago
- Yahoo
Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alfa in Head and Neck Cancer with CPS <1
SYDNEY, AUSTRALIA, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ('Immutep' or 'the Company'), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces it has received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa ('efti'), for first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1). Based on its review of the encouraging data in 1L HNSCC with CPS <1 from the TACTI-003 (KEYNOTE-C34) Phase IIb trial evaluating efti in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA® (pembrolizumab), the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS <1 patient segment and is supportive of the combination's further development. Paths for future clinical development and potential accelerated approval in light of the FDA's Project FrontRunner include a randomised registrational trial evaluating efti in combination with KEYTRUDA against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 - 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data. 'We are pleased with the FDA's feedback and guidance that underscores the high unmet need of head and neck cancer patients whose PD-L1 expression level is below one. The FDA feedback positions Immutep to evaluate options for future collaborative clinical development paths to bring a new, effective and safe treatment option to this underserved patient population,' said Marc Voigt, CEO of Immutep. 'Our primary focus clearly remains the pivotal TACTI-004 Phase III evaluating efti as first line therapy for non-small cell lung cancer and we are excited with its progress to date and the consistent, encouraging feedback we hear from physicians. This focus and additional considerations will be reviewed internally and discussed with stakeholders and potential strategic partners in regards to forward paths in head and neck cancer,' added Mr Voigt. Project FrontRunner is an FDA Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to consider when it may be appropriate to develop and seek approval of cancer drugs for advanced/metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. In this setting, advancing new effective therapies has the greatest potential to significantly improve quantity and quality of patients' lives. Patients with CPS <1 in 1L HNSCC represent a treatment population with high unmet medical need. Up to 20% of 1L HNSCC patients have CPS <1 and despite immunotherapy's progress in fighting cancer, anti-PD-1 therapy alone (without chemotherapy) is only approved for patients who express PD-L1 (CPS >1). All currently available treatment options for patients with PD-L1 CPS <1 include chemotherapy. About Immutep Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3's ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media:Eleanor Pearson, Sodali & Co.+61 2 9066 4071; U.S. Investors/Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000;
