Two Boston Scientific post-market surveillance studies confirm the unfavorable benefit-risk profile of now-withdrawn Boston Scientifics transvaginal m...
FDA grants Thermo Fisher Scientific emergency use authorizations for the TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath Covid-19 RNase P Comb...
FDA approves Eli Lillys rapid-acting insulin Lyumjev (insulin lispro-aabc injection) 100 units/mL for administration by continuous subcutaneous insuli...
Former Trump administration FDA commissioner Stephen Hahn urges more independence for the agency to prevent political interference.
FDA approves an Abbott PMA for the Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation who are at risk of ischemi...
Federal Register notice: FDA is reopening the comment period for a 7/23 notice on international drug scheduling convention for five narcotic drugs.
CBER says AstraZeneca can export three lots of Covid-19 vaccine drug substance manufactured at Emergent BioSolutions troubled contract manufacturing f...
Pfizer and BioNTech submit Phase 1 data to FDA to support the evaluation of a booster dose of their Covid-19 vaccine.