[ Price : $8.95]
FDA grants Veralox Therapeutics an orphan drug designation for VLX-1005 for treating heparin-induced thrombocytopenia.[ Price : $8.95]
Abeona Therapeutics conducts a Type B meeting with FDA on co-primary endpoints for its planned pivotal Phase 3 VIITAL study of gen...[ Price : $8.95]
A CDER report on PDUFA goals shows the Center increasingly used alternative inspection methods in FY 2020 due to the Covid-19 pand...[ Price : $8.95]
FDA posts an 11/5/2020 Form FDA-483 response from Bristol-Myers Squibb/Juno Therapeutics that addressed an FDA-483 with six inspec...[ Price : $8.95]
FDA denies an Outsourcing Facilities Association petition seeking a substitute definition of clinical need for use in determining ...[ Price : $8.95]
Pfizer says its Xeljanz did not meet non-inferiority criteria in a required post-marketing safety study.[ Price : $8.95]
Agios Pharmaceuticals say it will file an NDA in the second quarter for mitapivat for treating adults with pyruvate kinase deficie...[ Price : $8.95]
FDA warns Professional Compounding Centers of America about CGMP deviations and violations and other violations in its production ...