FDA grants Arcturus Therapeutics an orphan drug designation for ARCT-032 and its use to treat cystic fibrosis.
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.
AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.
The Association for Accessible Medicines raises several issues and concerns with FDAs proposal to develop a quality management maturity program.
Sen. Mike Crapo blocks an attempt by Sens. Dick Durbin and Charles Grassley to get unanimous consent to approve their bipartisan drug ad price disclos...
Federal Register notices: FDA publishes notices about the regulatory review period determinations for eight drug products sponsored by KemPharm, Apell...
