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Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
KNOE Monroe LA· 5 hours agoThe Food and Drug Administration posted its initial review of the drug Friday, ahead of a meeting of...
Moderna Scores FDA Approval For Its Second Product - Respiratory Syncytial Virus Vaccine
Benzinga· 4 hours agoOn Friday, the FDA approved Moderna Inc’s MRNA mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine to protect adults aged 60 and older from lower respiratory ...
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks· 19 hours agoFree Report) and Regeneron (REGN Quick QuoteREGN - Free Report) announced that the FDA extended the review period for a regulatory filing seeking label expansion for their ...
FDA rolls out platform technology guidance to smooth future regulatory encounters
FierceBiotech· 2 days agoTo speed up drug applications, the FDA has laid out new guidance on how to request a platform...
FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea
Pharmaceutical Technology via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has approved Teva Pharmaceuticals’ AUSTEDO XR...
FDA grants IND clearance for Spinogenix’s ALS treatment trial
Clinical Trials Arena via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has granted clearance for Spinogenix's investigational new...
FDA approves Beckman Coulter’s assay to assess heart failure
Medical Device Network via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has approved clinical diagnostics company Beckman...
FDA approves Amgen’s interchangeable biosimilar Bkemv
Pharmaceutical Technology via Yahoo Finance· 3 days agoThe US Food and Drug Administration (FDA) has approved Amgen's Bkemv (eculizumab-aeeb) as the first...
FDA Roundup: May 28, 2024
KSAN - KLST San Angelo· 3 days agoOn Friday, the FDA announced it had opened a new period for applications for grants to support the development and potential approval or conditional approval of new animal ...
FDA’s Delayed Menthol Cigarette Ban Puts Focus on Local Laws
Bloomberg Law· 2 days agoThe FDA’s stalled effort to ban menthol cigarettes and flavored cigars is shifting attention to states, where health groups and the tobacco industry are jockeying for influence ...