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...
ICU Medical recalls one lot of potassium chloride injection bags packaged in cases indicating 20 mEq per bag due to a mislabeling incident.
CDER posts a drug development qualifying tool to support treatments for alcohol use disorder products.
