[ Price : $8.95]
FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for it...[ Price : $8.95]
FDA issues an untitled letter to Bayer HealthCare Pharmaceuticals, citing misleading direct-to-consumer advertising for its prosta...[ Price : $8.95]
FDA commissioner Marty Makary outlines his goals to overhaul how the agency reviews new drugs, aiming to reduce early-stage regula...[ Price : $8.95]
New Bloomberg reporting that FDA is facing mounting internal strain and external criticism just over a year into commissioner Mart...[ Price : $8.95]
Clene says it plans to submit an NDA in the third quarter for its experimental amyotrophic lateral sclerosis therapy.[ Price : $8.95]
FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland fo...[ Price : $8.95]
FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy...[ Price : $8.95]
PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and ...