FDA notifies The Body Building that it is marketing unapproved cellular products intended to treat several diseases and conditions.
FDA permits KemPharm to proceed under an IND with its planned clinical investigation of KP879 and its use in treating stimulant use disorder.
PharmaCyte says it has started additional DNA sequencing studies sought by FDA for the companys CypCaps pancreatic cancer product.
FDA grants Veralox Therapeutics an orphan drug designation for VLX-1005 for treating heparin-induced thrombocytopenia.
Abeona Therapeutics conducts a Type B meeting with FDA on co-primary endpoints for its planned pivotal Phase 3 VIITAL study of gene therapy EB-101 in ...
A CDER report on PDUFA goals shows the Center increasingly used alternative inspection methods in FY 2020 due to the Covid-19 pandemic.
FDA posts an 11/5/2020 Form FDA-483 response from Bristol-Myers Squibb/Juno Therapeutics that addressed an FDA-483 with six inspection observations is...
FDA denies an Outsourcing Facilities Association petition seeking a substitute definition of clinical need for use in determining whether a drug can b...