Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophylm sought by FDA in a complete response letter, it ...
FDA releases the Form FDA-483 with three observations from a 2024 inspection at Indias MSN Life Sciences Unit II active pharmaceutical ingredient manu...
Resilient Pharmaceuticals resubmits an NDA for its midomafetamine capsules for a proposed indication of treating post-traumatic stress disorder.
President Trump signs an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recom...
Tenax Therapeutics says its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating the treatment in pat...
FDA sends ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its investigational radiopharmaceutical for gastroenteropancreatic n...
Abiomed and manufacturing partner Oscor issue a correction (Class 1 recall) for certain catheter introducers used with Impella heart pumps after ident...
FDA appoints Sarah Ibrahim as CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capacity since January.
