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FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company
The National Law Review· 2 hours agoOn May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug...
FDA warns parents to avoid infant formula distributed by Texas company due to contamination
WSB-TV 2 Atlanta· 2 hours agoWASHINGTON — (AP) — U.S. health officials warned parents to avoid powdered infant formula sold by a...
FDA’s review of MDMA for PTSD highlights study bias and safety concerns
Ars Technica· 31 minutes agoThe agency noted significant flaws in the design of the underlying clinical trials as well as safety...
FDA issues warning about baby formula that may be contaminated with dangerous bacteria
CNN via Yahoo News· 3 hours agoThe US Food and Drug Administration issued a warning Friday about baby formula that may be...
FDA approves Moderna’s mRNA RSV vaccine for older adults
CNN via Yahoo News· 5 hours agoThe US Food and Drug Administration has approved another vaccine that can help protect older people...
Moderna Scores FDA Approval For Its Second Product - Respiratory Syncytial Virus Vaccine
Benzinga via Yahoo Finance· 5 hours agoOn Friday, the FDA approved Moderna Inc’s (NASDAQ:MRNA) mRESVIA (mRNA-1345), an mRNA respiratory...
FDA Extends Review Deadline For Regeneron/Sanofi's Dupixent For 'Smoker's Lungs' Disease
Benzinga via AOL· 9 hours agoOn Friday, the FDA extended the target action date of priority review of supplemental application...
FDA staff questions safety of ecstasy for PTSD
Axios· 3 hours agoWhy it matters: The findings cast new doubts on what could become the first psychedelic-based treatment approved in the U.S. ahead of a June 4 meeting...
FDA Levels Penalties Against Retailers for Elf Bar Sales
Convenience Store News· 17 hours agoOperators who sold unauthorized tobacco products may be liable for more than $20,000 each....
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks via Yahoo Finance· 11 hours agoPer the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication...