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.
FDA gives Aurobindo Pharma a four-observation Form FDA-483 after inspecting the firms Unit XIV active pharmaceutical ingredient (non-antibiotic) manuf...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on ANDA bioequivalence study designs.
New FDA research on direct-to-consumer television ads finds that disclosures could help viewers in differentiating between progression-free survival a...
