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FDA accepts for priority review a Gilead Sciences NDA for lenacapavir for twice-yearly use in preventing HIV as pre-exposure proph...[ Price : $8.95]
Citizens MAHA files a petition asking HHS and FDA to suspend and revoke EUAs and BLAs for mRNA Covid-19 vaccines and conduct a ful...[ Price : $8.95]
Editor Jim Dickinson posts his obituary of Larry R. Pilot (84), who co-founded FDAs first medical device bureau and parlayed his i...[ Price : $8.95]
ICU Medical recalls one lot of potassium chloride injection bags packaged in cases indicating 20 mEq per bag due to a mislabeling ...[ Price : $8.95]
CDER posts a drug development qualifying tool to support treatments for alcohol use disorder products.[ Price : $8.95]
FDA places a clinical hold on a Phase 3 study evaluating Modernas trivalent vaccine against norovirus (mRNA-1403) after a case of ...[ Price : $8.95]
FDA approves Sanofi-Aventis Merilog (insulin-aspart-szjj) as a biosimilar to Novo Nordisks Novolog (insulin aspart) for improving ...[ Price : $8.95]
Abiomed recalls its Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps to update their use instructions ...