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Ecstasy’s path to approval for PTSD treatment faces doubts from FDA staff
Washington Post· 15 minutes agoThe U.S. Food and Drug Administration released an analysis Friday that raised extensive questions...
FDA warns parents to avoid infant formula distributed by Texas company due to deadly bacteria
WDBJ 7 Roanoke· 26 minutes agoU.S. health officials warned parents to avoid powdered infant formula sold by a Texas dairy...
FDA approves Moderna’s mRNA RSV vaccine
The Hill via Yahoo News· 7 hours agoThe Food and Drug Administration (FDA) has approved Moderna’s RSV mRNA vaccine for adults older than 60 years. The approval makes RSV the second disease...
Moderna Scores FDA Approval For Its Second Product - Respiratory Syncytial Virus Vaccine
Benzinga via Yahoo Finance· 2 hours agoOn Friday, the FDA approved Moderna Inc’s (NASDAQ:MRNA) mRESVIA (mRNA-1345), an mRNA respiratory...
Moderna secures a second FDA vaccine approval as Spikevax sales plummet
Fast Company Magazine· 1 hour agoThis will be the only RSV vaccine available in single-dose prefilled syringes and will be sold under...
The FDA is weighing whether to approve MDMA for PTSD. Here's what that could look like for patients.
CBS News· 3 hours agoDetails of the FDA's proposal were published Friday in a set of documents released by the agency...
FDA sets review date for Iterum's urinary infection drug By Investing.com
Investing.com· 4 hours agoThe FDA's acceptance of the New Drug Application (NDA) resubmission marks a significant step for...
JD Supra: FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
JD Supra· 2 hours agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage ...
FDA Extends Review Deadline For Regeneron/Sanofi's Dupixent For 'Smoker's Lungs' Disease
Benzinga via Yahoo Finance· 6 hours agoThe revised target action date is September 27, 2024. The FDA accepted the application in February,...
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks via Yahoo Finance· 8 hours agoPer the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication...