An FDA advisory committee briefing document reveals reviewer concerns about safety and efficacy issues in a Lykos Therapeutics NDA for midomafetamine ...
FDA approves a Moderna BLA for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus vaccine for adults aged 60 years and older.
FDA approves an Avita Medical PMA supplement for the Recell GO System, its next-generation autologous cell harvesting device.
Federal Register notice: FDA makes available a draft guidance Platform Technology Designation Program for Drug Development.
Federal Register notice: FDA decides to terminate the Science Advisory Board to the National Center for Toxicological Research because it has become o...
Researchers at Yale and Emory say they find little evidence to support the notion that surrogate markers used in non-oncologic drug accelerated approv...
FDA approves Bristol Myers Squibbs Breyanzi (lisocabtagene maraleucel; liso-cel) for treating adult patients with relapsed or refractory mantle cell l...
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with chemotherapy for the first-line metastatic m...
