FDA puts a clinical hold on the Larimar Therapeutics clinical development program for CTI-1601 to treat Friedreichs ataxia.
FDA updates its guidance on Covid-19 EUAs to reflect that it may decline to review and process further EUA requests other than those for vaccines whos...
FDA tells Travere Therapeutics that data from the ongoing Phase 3 DUPLEX study of sparsentan for treating focal segmental glomerulosclerosis (FSGS) ar...
FDA denies a Vifor Fresenius request for five-year NCE exclusivity for its Velphoro.
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.