FDA approves Roches cobas malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals in reducing potential risks of patient i...
In the wake of this weeks U.S. Supreme Court oral arguments on the abortion drug mifepristone, a new Axios/Ipsos poll finds that most Americans say th...
FDA releases a final guidance entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports.
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FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).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.
