Federal Register notice: FDA announces a 2/28 to 3/1 Vaccines and Related Biological Products Advisory Committee meeting to discuss two BLAs for respi...
CDER says Lexicon has failed to justify its request for an agency hearing on the Centers refusal to approve the companys NDA for sotagliflozin to help...
CDER releases its proposed 2023 guidance agenda showing 98 planned new and revised guidances in 18 categories.
FDA publishes a draft guidance with recommendations about developing drugs for treating early Lyme disease as manifested by erythema migrans.
FDA says IBSA Pharma is recalling 27 lots of Tirosint-Sol oral solution due to subpotency.
Federal Register notice: FDA announces a 4/4-5 advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Resea...
Pfizer says it gained an expanded indication in late December for Ibrance (palbociclib) to include its use in combination with an aromatase inhibitor ...
FDA clears a Clarius Mobile Health 510(k) for its new MSK (musculoskeletal) AI model, which automatically identifies and measures tendons in the foot,...
