University of Pennsylvania medical school professor Jason Karlawish makes the case for FDA to require a detailed REMS for new Alzheimers disease drugs...
FDA explains its reasoning for granting in part and denying in part a Boehringer Ingelheim 2012 petition concerning its Spiriva Handihaler and other t...
The International Council for Harmonization Assembly approves the addition of three new topics for harmonization.
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...
