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...
The Trump administration adds a gender ideology statement to two Web pages on draft guidances that FDA was ordered by a federal judge to restore earli...
Bristol Myers Squibb says a Phase 3 trial evaluating Opdualag (nivolumab and relatlimab-rmbw) for treating patients with completely resected stage III...
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...
