Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rigel Pharmaceuticals Tavalisse.
CDER Office of Manufacturing Quality director Francis Godwin warns that FDA investigators are paying close attention to pharmaceutical water systems d...
FDA approves Mallinckrodts Terlivaz (terlipressin) injection for improving kidney function in certain adults with hepatorenal syndrome.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Conturas Bulkamid Urethral Bulking System.
The Washington Legal Foundation says the 2nd Circuit Court of Appeals should affirm a lower courts dismissal of a suit against Forest Laboratories bec...
Federal Register notice: FDA issues a final rule specifying the deadline and content for submission of annual summaries under the Right to Try Act of...
Vanda Pharmaceuticals files a lawsuit against FDA seeking an order to compel it to publish in the Federal Register a notice of opportunity for a heari...
FDA releases a form FDA-483 with three observations from an inspection at an Aurobindo active pharmaceutical ingredient manufacturing facility in Andh...
