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FDA approves Moderna’s mRNA RSV vaccine for older adults
CNN via Yahoo News· 6 days agoThe US Food and Drug Administration has approved another vaccine that can help protect older people...
High Confidence AD Drug Donanemab Will Get FDA Panel Nod
Medscape· 3 days agoThe FDA delayed its decision on whether to approve the antiamyloid agent back in March, opting...
The FDA may approve psychedelics for treating PTSD. Here's what to know
Quartz· 4 days agoThe public benefit company Lykos Therapeutics submitted a new drug application late last year to the...
FDA Panel Rejects MDMA-Assisted Therapy For PTSD
Forbes· 1 day agoTherapeutics, a company formed by the Multidisciplinary Association for Psychedelic Studies (MAPS) to develop the treatment. After listening to public...
FDA Advisers Overwhelmingly Oppose Approval of MDMA As a Psychotherapeutic Catalyst
Reason.com via Yahoo News· 1 day ago"We remain committed to working with the FDA to address outstanding questions so that we may find a...
FDA lays out donanemab concerns ahead of meeting, as Lilly vigorously defends safety
FierceBiotech· 8 hours agoThe docs for Eli Lilly’s donanemab advisory committee meeting are in: the FDA has raised concerns...
FDA confirms robotic prostatectomy survival rates match traditional surgery By Investing.com
Investing.com· 1 day agoThe U.S. Food and Drug Administration (FDA) has approved a labeling revision for Intuitive's da...
JD Supra: FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests
JD Supra· 1 day agoRule that will regulate laboratory developed tests (LDTs) as in vitro diagnostic (IVD) medical devices. FDA published a four-year enforcement discretion phaseout plan as part ...
FDA approves Moderna’s RSV vaccine mRESVIA
Pharmaceutical Technology via Yahoo Finance· 4 days 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...
mRESVIA’s FDA approval paves the way for mRNA vaccines across multiple indications
Clinical Trials Arena via Yahoo Finance· 11 hours agoModerna’s respiratory syncytial virus (RSV) vaccine mRESVIA has received US Food and Drug...