FDA unveils a new pilot program to prioritize the review of certain generic drug ANDAs in an effort to boost domestic pharmaceutical manufacturing and...
FDA commissioner Marty Makary talks with CNNs Sanjay Gupta and says he wants to speed up the nations drug approval process without compromising safety...
A new Brookings Institution commentary raises concerns about FDAs new Commissioners National Priority Voucher pilot program.
FDA approves the second generic copy of abortifacient mifepristone, a move that prompted mixed reactions from lawmakers and advocacy groups.
FDA posts a five-item FDA Form-483 after inspecting Covid-19 vaccine maker Serum Institute of Indias Maharashtra manufacturing facility.
Rocket Pharmaceuticals withdraws its BLA for RP-L102 (mozafancogene autotemcel), an investigational gene therapy for treating Fanconi Anemia.
Amgen says its Repatha met the primary endpoints in a landmark Phase 3 trial, making it the only PCSK9 inhibitor to demonstrate a significant reductio...
FDA posts a four-item Form FDA 483 that was issued to Laboratorios Grifols after a 7/2024 inspection of the firms drug manufacturing facility in Barce...
