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The FDA is weighing whether to approve MDMA for PTSD. Here's what that could look like for patients.
CBS News· 15 minutes 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· 43 minutes agoThe FDA's acceptance of the New Drug Application (NDA) resubmission marks a significant step for...
FDA approves Moderna's RSV vaccine, its second marketed product
USA Today· 30 minutes agoS. Food and Drug Administration has approved Moderna's respiratory syncytial virus vaccine, the...
FDA approves Moderna’s mRNA RSV vaccine
The Hill via AOL· 3 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...
FDA Extends Review Deadline For Regeneron/Sanofi's Dupixent For 'Smoker's Lungs' Disease
Benzinga via Yahoo Finance· 3 hours agoThe revised target action date is September 27, 2024. The FDA accepted the application in February,...
FDA staff questions safety of ecstasy for PTSD
Axios· 1 hour 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 responds to senator’s letter that calls out ‘FDA’s failure to act’ on NOW’s test results
Nutraingredients.com· 3 hours agoDuncan, chair of the House Subcommittee on Energy, Climate and Grid Security. “I believe FDA’s...
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks via Yahoo Finance· 5 hours agoPer the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication...
Invivyd aligns with FDA on rapid mAb trial pathway By Investing.com
Investing.com· 59 minutes agoInvivyd Inc. (NASDAQ: IVVD), a biopharmaceutical company, has announced an agreement with the U.S....
Clinical lab industry sues to block FDA’s new oversight of lab-developed tests
FierceBiotech· 3 hours agoIn its lawsuit (PDF), filed this week in East Texas federal court, the American Clinical Laboratory...