FDA approves Genentechs Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection for treating patients with HER2-positive early b...
Federal Register notice: FDA announces a public meeting and an opportunity for public comment on Patient Perspectives on the Impact of Rare Diseases: ...
Federal Register notice: FDA amends its regulations to reflect a change of address for CDERs Office of Generic Drugs Document Room from Rockville, MD,...
The Justice Department says Lehigh Valley Technologies, a human drug developer, is settling a False Claims Act suit charging it with fraudulently obta...
Three stakeholders comment and make suggestions on an FDA draft guidance on biomarker qualification.
Physio-Control begins a Class 1 recall of its LifePak 15 monitor/defibrillator because the device may lockup after a shock is delivered.
Two stakeholders voice support for FDA guidance addressing nontruthful and misleading communications about biologics and biosimilars.
Federal Register notice: FDA submits to OMB an information collection extension entitled Formal Dispute Resolution; Appeals Above the Division Level....