Getinge’s recall of its Cardiohelp for problems with its emergency drive has been identified by the FDA as a Class I recall — the most serious type of recall as…

Eight of 10 high-cost drugs — with increases that totaled $1.27 billion — had substantial price increases in 2022 that were not supported by new clinical evidence, a new report…

Teva Pharmaceuticals has asked a Colorado federal judge to keep alive its lawsuit challenging the state’s epinephrine auto-injector (epi-pen) affordability program as unconstitutional, arguing that suing in state court for…

HHS’s fall unified agenda of proposed rules for the FDA includes a new rule that revokes two old rules that have either been superseded or do not reflect current agency…

As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…

A survey conducted among attendees of Team NB’s second in vitro device regulation (IVDR) training seminar reflected the worrisome trend of foot-dragging among manufacturers in making an application to a…

Angering drugmakers, the Biden Administration announced Thursday that it’s supporting a previously unused, obscure and controversial regulatory authority called “march-in” rights to achieve lower prices on taxpayer-funded drugs deemed too…

Over the past week, the FDA issued final guidance on verification systems for certain prescription drugs under the Drug Supply Chain Security Act and draft guidances on the interim policy…

In this edition of Quick Notes, we review recent FDA drug approvals of Jaypirca for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma, Ogsiveo for desmoid tumors who…

Two cell-based gene therapies to treat sickle cell disease — Casgevy (exagamglogene autotemcel or exa-cel) and Lyfgenia (lovotibeglogene autotemcel or lovo-cel) — received FDA approval Friday, marking the first treatments…