Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bayers Aliqopa (copanlisib dihydrochloride).
Federal Register notice: FDA posts a list of 18 information collections that have been approved by OMB.
FDA releases the 2022 medical countermeasures annual report covering 14 key agency activities to support the development of and access to medical coun...
FDA says Concert Pharmaceuticals deuruxolitinib can retain its breakthrough therapy designation to treat alopecia areata.
FDA accepts for priority review a Galera Therapeutics NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with hea...
The latest Foley Hoag product liability update covers a Massachusetts federal courts ruling on three aspects of a case involving Corcept Therapeutics ...
Researchers say the use of pediatric extrapolation in a six-year period increased the rate of new and expanded pediatric indications.
The outgoing director of the CBER Office of Tissues and Advanced Therapies, Wilson Bryan, expresses concern about the length of confirmatory trials ne...
