FDA agrees to a PolyPid Phase 3 trial (SHIELD II) design revision evaluating D-PLEX 100 (doxycycline) for preventing abdominal colorectal surgical sit...
FDA denies a Public Citizen petition that sought a Boxed Warning for all sodium-glucose cotransporter-2 inhibitor drugs contraindicating their use in ...
FDA updates its CDRH Portal to allow users to track the progress of pre-submissions for obtaining feedback on potential marketing applications.
FDA approves a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating adults with indolent systemic mastocytosis.
Novo Nordisk plans to file an NDA for obesity drug semaglutide 50 mg tablets after announcing that the Phase 3a OASIS 1 trial met its primary endpoint...
Rain Oncology says it will cease further development of milademetan in dedifferentiated liposarcoma after reporting disappointing topline data from a ...
Federal Register notice: FDA withdraws approval of Abbotts NDA for Cyclert (pemoline) tablets, indicated for treating attention-deficit/hyperactivity ...
FDA approves an Opiant Pharmaceuticals NDA for Opvee (nalmefene HCl) nasal spray for the emergency treatment of a known or suspected opioid overdose.
