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FDA approves Moderna’s RSV vaccine mRESVIA
Pharmaceutical Technology via Yahoo Finance· 1 hour 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...
The FDA may approve psychedelics for treating PTSD. Here's what to know
Quartz· 27 minutes agoThe public benefit company Lykos Therapeutics submitted a new drug application late last year to the...
RNT Health Insights’ gastric cancer detection tool receives FDA BDD
Medical Device Network via Yahoo Finance· 42 minutes 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· 2 days agoModerna's vaccine was approved for the prevention of RSV-associated lower respiratory tract disease...
FDA Approves First Interchangeable Biosimilar for Two Rare Diseases
WROC Rochester· 5 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...
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
KABC 7 Los Angeles· 14 hours agoThe Food and Drug Administration posted its initial review of the drug Friday, ahead of a meeting of...
FDA Approves Nonstimulant Liquid Onyda XR for ADHD
Medscape· 4 days agoThe centrally acting alpha2-adrenergic agonist allows for nighttime dosing and can be used with stimulants, the drug's manufacturer says.
FDA approves Moderna’s mRNA RSV vaccine for older adults | CNN
CNN.com· 3 days agoThe US Food and Drug Administration has approved another vaccine to help protect older people from...
FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea
Pharmaceutical Technology via Yahoo Finance· 4 days agoBoth are FDA-approved VMAT2 inhibitors for adults to treat TD and chorea associated with HD. A...
