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FDA approves Moderna's RSV shot for older adults
Becker’s Hospital Review· 13 hours agoThe FDA has given the green light to Moderna's mRNA-based respiratory syncytial virus vaccine, specifically for older adults, the drugmaker announced May 31. "This approval ...
Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 13 hours agoAs detailed in our prior analysis (here), the final rule amended the FDA’s existing regulations to make explicit the agency’s interpretation that LDTs are “devices” under ...
FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men
Denver Post· 1 day agoThe federal government in 2020 and 2023 changed who it said could safely donate organs and blood,...
FDA’s Final Rule on IVDs: a stop gap en route to the VALID Act?
Medical Device Network via Yahoo Finance· 5 days agoAfter years of back and forth with industry, the FDA has made explicit that IVDs are medical devices...
Psychoactive drugs are having a moment. The FDA will soon weigh in
The State· 12 hours agoPsychoactive drugs are having a moment. Investors are piling into the nascent field, and a host of medications based on MDMA, LSD, psychedelic mushrooms, ketamine, the South American plant mixture ...
FDA Conditionally Approves Eli Lilly's Thyroid Cancer Drug For Pediatric Patients With Certain...
Benzinga via AOL· 5 days agoWednesday, the FDA granted accelerated approval to Eli Lilly And Co’s (NYSE:LLY) selpercatinib...
More than a million bottles of popular water brand are being recalled
Birmingham News· 2 hours agoNearly 1.9 million Fiji water bottles have been recalled after testing positive for bacteria and...
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
ABC7 News· 1 day agoThe Food and Drug Administration posted its initial review of the drug Friday, ahead of a meeting of...
FDA Considers a Big Change to Decaf Coffee
newser· 1 day agoThe request: Groups including the Environmental Defense Fund petitioned the FDA to ban the carcinogen, which is used "in many different industries...
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks via Yahoo Finance· 3 days agoPer the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication...