FDA launches a Drug Supply Chain Security Portal as part of the CDER Next Gen Portal.
FDA denies for reasons of safety a 2017 petition seeking approval to submit an ANDA for a generic form of Bristol-Myers Squibbs Eliquis with a higher ...
FDA posts a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals Windsor, CT outsourcing facility.
Federal Register notices: FDA publishes notices about the regulatory review period determinations for eight drug products sponsored by KemPharm, Apell...
FDA accepts for review a Karuna Therapeutics NDA for KarXT (xanomeline-trospium) for treating schizophrenia in adults.
Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.
A CDER study examines generic nasal spray distribution factors that could speed the development of generic sprays.
FDA clears a Vivos Therapeutics 510(k) for its Vivos CARE (Complete Airway Repositioning and/or Expansion) appliances for treating adults with severe ...
