FDA grants Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-302, a gene therapy designed to correct a disease-causing m...
FDA grants Thermosome an orphan drug designation for THE001 and its use in treating soft tissue sarcomas.
Eli Lillys Zepbound (tirzepatide) demonstrates significantly greater weight loss than Novo Nordisks Wegovy (semaglutide) in a head-to-head trial of th...
FDA approves a Teal Health PMA for the Teal Wand, the first at-home vaginal sample, self-collection device for cervical cancer screening.
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...
