Federal Register notice: FDA determines for patent term extension purposes the regulatory review periods for two drug products Janssens Erleada and A...
Federal Register notice: FDA announces a 3/7 Vaccines and Related Biological Products Advisory Committee meeting to discuss the flu vaccines strain se...
The Senate Judiciary Committee clears five drug-related bills that would prohibit brand manufacturers from blocking/delaying generic drug competition,...
FDA grants full approval to GSKs Jemperli (dostarlimab-gxly) for certain adult patients with mismatch repair deficient (dMMR) recurrent or advanced en...
Federal Register notice: FDA issues an order debarring Hassan Tahsildar for two years from providing services to a person that has an approved or pend...
CBER director Peter Marks says the Center is recruiting 125 new staff to work on cell and gene therapies during a transitional 2023.
FDA grants an emergency use authorization for a BD molecular test that differentiates between Covid-19, the flu, and RSV.
FDA medical reviewers raise concerns about GlaxoSmithKlines proposed trials of Jemperli to support a future BLA accelerated approval for some rectal c...
