Two SheppardMullin attorneys say that drug manufacturers seeking accelerated approval should be aware that 10% of drugs approved through the pathway u...
Federal Register notice: FDA announces a 6/14 public workshop entitled FDA Science Forum 2023.
FDA approves a Medtronic PMA for its Micra AV2 and Micra VR2 next-generation miniaturized, leadless pacemakers.
Astellas Pharma and Pfizer plan to discuss with FDA the filing of a supplemental NDA for Xtandi (enzalutamide) plus leuprolide for use in men with non...
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) that seeks an expanded indication to include ...
Representatives Sara Jacobs (D-CA) and Cory Mills (R-FL) introduce bipartisan legislation to minimize and prevent future drug shortages.
FDA sends Ascendis Pharma a complete response letter on its NDA for TransCon PTH (palopegteriparatide), indicated for treating adults with hypoparathy...
FDA issues Princeton BioMeditech an emergency use authorization for its Covid-19 Antigen Rapid Test for Home Use.
