FDA has extended by three months an ARS Pharmaceuticals NDA for neffy (intranasal epinephrine) for treating allergic reactions, including anaphylaxis.
FDA approves Surmodics SurVeil drug-coated balloon and its use in percutaneous transluminal angioplasty.
The CDER Office of Pharmaceutical Quality FY 2022 report on pharmaceutical quality shows a significant increase in drug site surveillance inspections.
Senators Gary Peters (D-MI) and Joni Ernst (R-IA) introduce bipartisan legislation to ensure the government is better prepared to address threats pose...
FDA approves a Pfizer NDA for Talzenna (talazoparib) with Astellas Xtandi (enzalutamide) for treating certain patients with gene-mutated metastatic ca...
The Harvard Drug Group recalls a single lot of dronabinol capsules (2.5 mg) and ziprasidone hydrochloride capsules (20 mg) after receiving a customer ...
FDA extends by three months its review of a GSK NDA for momelotinib, indicated for treating myelofibrosis patients with anemia.
Philips issues an urgent field safety notice about its Azurion and Allura Xper systems installed with the FlexMove option, which could pose a risk for...
