Federal Register notice: FDA denies a request for a hearing and issues an order debarring Trang Doan Nguyen for five years from providing services in ...
A new analysis from the RAND Corporation says biosimilar approvals should help cut healthcare spending by $54 billion over the next decade.
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Baxters Obizur is 4,216 days.
Federal Register notice: FDA makes available a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets.
FDA determines for patent extension purposes that the regulatory review period for Baxters Obizur is 4,216 days.
FDA approves Janssen Biotechs Simponi Aria (golimumab) for treating adults with active psoriatic arthritis and active ankylosing spondylitis.
FDA approves a GlaxoSmithKline BLA for its Shingrix (zoster vaccine recombinant, adjuvanted) for preventing shingles (herpes zoster) in adults aged 50...
Octapharma USA withdraws two lots of Octagam 10% [immune globulin intravenous (human)] liquid preparation] that is labeled with lot numbers K724B8541 ...