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FDA grants Invitae a de novo market authorization for its Common Hereditary Cancers Panel for identifying germline variants associ...[ Price : $8.95]
Federal Register notice: FDA is announcing an 11/7 Radiological Devices Panel of the Medical Devices Advisory Committee meeting to...[ Price : $8.95]
Federal Register notice: FDA announces the revocation of 11 Covid-related Emergency Use Authorizations after the authorization hol...[ Price : $8.95]
Federal Register notice: FDA releases a draft guidance entitled Stimulant Use Disorders: Developing Drugs for Treatment.[ Price : $8.95]
CBS News says a drug supply chain association issued an alert that FDA is investigating counterfeit Ozempic.[ Price : $8.95]
CDER says its NextGen Portal is now accepting Over-the-Counter Monograph Order Requests.[ Price : $8.95]
Coherus BioSciences resubmits a BLA supplement for Udenyca Onbody, the company's on-body injector presentation of Udenyca (pegfilg...[ Price : $8.95]
AstraZeneca suggests several things FDA could add to a draft guidance on QTc information in drug and biologic labeling.