FDA grants Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-302, a gene therapy designed to correct a disease-causing m...
New CBER director Vinay Prasad defends his past criticisms of vaccines and says he is not anti-vax and promises that the Center will strive to always ...
FDA grants MeiraGTx Holdings a regenerative medicine advanced therapy designation for gene therapy AAV-GAD and its use for treating Parkinsons disease...
FDA prepares to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act, which expires 9/2027.
FDA commissioner Marty Makary says discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorization to a full approval...
Paradigm Therapeutics plans an NDA submission in the second half of this year for Zorblisa (SD-101), as a topical whole-body treatment for all subtype...
FDA approves a Teal Health PMA for the Teal Wand, the first at-home vaginal sample, self-collection device for cervical cancer screening.
FDA again misses a user fee review action decision in the wake of mass staff cuts, the third miss in a month this time it's a GSK Nucala sNDA for tre...
