FDA launches effort to review infant formulas
The Food and Drug Administration (FDA) announced a new initiative Tuesday titled 'Operation Stork Speed' aimed at reviewing infant formula ingredients and expanding available options.
According to the FDA, the goal of its new initiative is to ensure the 'quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.'
In 2022, the U.S. infant formula supply was hampered following the temporary closure of Abbott Nutrition's Michigan facility due to bacteria contamination. The FDA shut down the facility for months, and a nationwide recall was issued.
'The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,' Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement, calling this action 'critical' to his Make America Healthy Again agenda.
The FDA's response to the 2022 infant formula crisis has been scrutinized, with the Office of Inspector General for the Department of Health and Human Services finding that the agency was dangerously slow in responding to complaints about conditions at the facility. The blowback from this led in part to the FDA reorganizing its structure in 2024.
In its announcement Tuesday, the FDA listed a set of actions it says will support nutritional adequacy and supply of infant formula. These include conducting the 'first comprehensive update and review of infant formula nutrients by the FDA since 1998,' increasing testing for heavy metals and extending the personal importation policy.
The agency also said it will be encouraging companies to develop new infant formulas.
Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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The live webcast can be accessed by visiting the Investors section of the Company's website at Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. An archive of the webcast will be available on the Company's website. About ZUSDURI ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen's proprietary RTGel ® technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. About Non-Muscle Invasive Bladder Cancer (NMIBC) LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at About UroGen Pharma Ltd. UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen's sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat low-grade upper tract urothelial cancer and ZUSDURI (mitomycin) for intravesical solution, UroGen's first product to treat recurrent LG-IR-NMIBC are both designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit to learn more or follow us on X, @UroGenPharma. APPROVED USE FOR ZUSDURI ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working. IMPORTANT SAFETY INFORMATION You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI. Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose. Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose. are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose. How will I receive ZUSDURI? You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider's instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines. After receiving ZUSDURI: ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours. To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water. Clothing that comes in contact with urine should be washed right away and washed separately from other clothing. The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436. Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information. ZUSDURI ™ is a trademark and UroGen ® is a registered trademark of UroGen Pharma, Ltd. Copyright©2025 UroGen Pharma, Inc. All rights reserved. Forward-Looking Statements This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; the potential benefits to patients and opportunities for ZUSDURI; the potential of UroGen's proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin; and UroGen's sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as 'can,' 'expect,' 'may,' 'plan,' 'potential,' 'target,' 'will' or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen's industry; the scope, progress and expansion of developing and commercializing UroGen's products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen's ability to attract or retain key management, members of the board of directors and other personnel; UroGen's RTGel technology and ZUSDURI may not perform as expected; new data relating to ZUSDURI, including from spontaneous adverse event reports and from the ongoing ENVISION trial, may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; and UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology. 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