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The FDA may approve psychedelics for treating PTSD. Here's what to know
Quartz· 1 hour agoThe public benefit company Lykos Therapeutics submitted a new drug application late last year to the...
FDA approves Moderna’s RSV vaccine mRESVIA
Pharmaceutical Technology via Yahoo Finance· 2 hours agoIn 2023, Moderna agreed to establish an mRNA manufacturing facility in Kenya. The new advanced facility will have the capacity to produce up to 500...
Is Moderna Stock a Buy Now That It's a 2-Product Company?
Motley Fool via Yahoo Finance· 19 minutes agoBiotech stocks generally rise after a product they spent years developing earns marketing approval,...
RNT Health Insights’ gastric cancer detection tool receives FDA BDD
Medical Device Network via Yahoo Finance· 2 hours agoThe FDA BDD is granted to medical devices that come with reasonable clinical proof to provide major...
US FDA approves Moderna's RSV vaccine with lower-than-expected efficacy in its label
Reuters· 3 days agoModerna's vaccine was approved for the prevention of RSV-associated lower respiratory tract disease...
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
WTVD-TV 11 Raleigh-Durham· 15 hours agoIn their assessment, FDA scientists said that patients who received MDMA and talk therapy showed...
ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests
The Herald Journal· 6 hours agoARUP Laboratories is backing a federal lawsuit filed by the American Clinical Laboratory Association (ACLA) challenging the FDA's final rule to regulate laboratory-developed ...
Psychoactive drugs are having a moment. The FDA will soon weigh in
The State· 2 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 Approves First Interchangeable Biosimilar for Two Rare Diseases
WROC Rochester· 6 days agoToday, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases ...
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...