A Med Device Online guest column lists and analyzes FDAs top five data quality citation issues in 2024.
FDA approves a GSK BLA for Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for preventing invasive meningococcal disease.
The Trump Administration fires hundreds of FDA probationary employees over the weekend as part of its efforts to trim government fat.
FDA approves a Deciphera Pharmaceuticals NDA for Romvimza (vimseltinib) for treating adult patients with symptomatic tenosynovial giant cell tumors.
Based on partially successful Phase 2 study results, AlgoTx says it plans to continue developing ATX01 for chemotherapy-induced peripheral neuropathy.
FDA accepts for priority review a Gilead Sciences NDA for lenacapavir for twice-yearly use in preventing HIV as pre-exposure prophylaxis.
Citizens MAHA files a petition asking HHS and FDA to suspend and revoke EUAs and BLAs for mRNA Covid-19 vaccines and conduct a full safety review.
Editor Jim Dickinson posts his obituary of Larry R. Pilot (84), who co-founded FDAs first medical device bureau and parlayed his inside knowledge to b...
