FDA extends by three months its review of an Applied Therapeutics NDA for govorestat (AT-007) for treating classic galactosemia.
FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).
FDA approves Akeibas Vafseo to treat anemia in some adults with chronic kidney disease.
Aldeyra Therapeutics says it will conduct a dry eye chamber clinical trial of its reproxalap in hopes of resubmitting an NDA for treating dry eye dise...
FDA releases the form FDA-483 that was issued following a 2019 inspection at the Fusion IV outsourcing facility in Los Angeles, CA.
The CDRH Accreditation Scheme for Conformity Assessment pilot final report says the effort met and sometimes exceeded agency expectations.
FDA says Amneal is recalling four lots of vancomycin HCl for oral solution because some of the bottles were over-filled during the manufacturing proce...
Eugia U.S. recalls one lot of methocarbamol injection due to a customer product complaint about the presence of white particles floating inside a vial...
