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...
Abiomed recalls its Impella 5.5 with SmartAssist catheter, an intravascular micro axial blood pump that supports a patients circulatory system, due to...
