FDA and the FTC warn five companies they are marketing unapproved new drugs as dietary supplements to treat infertility.
FDA approves a Myovant Sciences and Pfizer NDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing heavy me...
FDA warns Biotek India about CGMP violations in its manufacturing of OTC drugs and its marketing of a misbranded unapproved new OTC drug product.
FDA warns Smart Womens Choice that its vaginal contraceptive cream is an unapproved new drug.
Federal Register notice: FDA determines that Abraxis Pharmaceuticals injectable manganese sulfate 0.1 mg/mL was not withdrawn due to safety or effecti...
Federal Register notice: FDA makes available a final guidance entitled Bispecific Antibody Development Programs.
Federal Register notice: FDA sends to OMB an information collection revision on Shortages Data Collections.
FDA reports on South Koreas actions to combat Covid-19, particularly involving diagnostic tests.