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...
The Justice Department resolves civil claims requiring Zoll Medical to pay $400,000 for selling Chinese-made products to the federal government.
FDA grants Genmab an accelerated approval for its BLA for Epkinly (epcoritamab-bysp) injection for treating adult patients with relapsed or refractory...
FDA approves a Krystal Biotech BLA for Vyjuvek, a herpes-simplex virus type 1 vector-based gene therapy for treating wounds in patients older than six...
