FDA warns Indias Tyche Industries about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Harmed Americans for Reform in Medical Device Safety asks FDA to repost two safety communications and to analyze and post its findings on two studies ...
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.
