FDA grants Invitae a de novo market authorization for its Common Hereditary Cancers Panel for identifying germline variants associated with hereditary...
Federal Register notice: FDA is announcing an 11/7 Radiological Devices Panel of the Medical Devices Advisory Committee meeting to discuss proposed cl...
Federal Register notice: FDA announces the revocation of 11 Covid-related Emergency Use Authorizations after the authorization holders requested they ...
Federal Register notice: FDA releases a draft guidance entitled Stimulant Use Disorders: Developing Drugs for Treatment.
CBS News says a drug supply chain association issued an alert that FDA is investigating counterfeit Ozempic.
CDER says its NextGen Portal is now accepting Over-the-Counter Monograph Order Requests.
Coherus BioSciences resubmits a BLA supplement for Udenyca Onbody, the company's on-body injector presentation of Udenyca (pegfilgrastim-cbqv), a bios...
FDAs Oncologic Drugs Advisory Committee votes 10 to 2 that the CodeBreak 200 confirmatory study cannot be reliably interpreted as the basis for Amgens...
