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.
FDA places a clinical hold on a Phase 3 study evaluating Modernas trivalent vaccine against norovirus (mRNA-1403) after a case of Guillain-Barr syndro...
FDA approves Sanofi-Aventis Merilog (insulin-aspart-szjj) as a biosimilar to Novo Nordisks Novolog (insulin aspart) for improving glycemic control in ...
