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Novavax awaits FDA decision on whether its next COVID shot can be offered in US
AOL· 11 hours agoNovavax's updated vaccine targets a variant called JN.1, which is in line with European recommendations. The European Union's regulator told vaccine makers last month to update their vaccines ...
FDA cancer lead Harpreet Singh departs to serve as Precision for Medicine CMO
FierceBiotech· 1 day agoFDA oncology division director Harpreet Singh, M.D., has left the agency to join Precision for...
Blood test to detect colon cancer could move a step closer to FDA approval in the US
CNN.com· 1 day agoThe FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met to...
FDA considers 2nd blood test for colon cancer — but advisers note concerns
Becker’s Hospital Review· 1 day agoFDA advisers have recommended the approval of Guardant Health's blood test to detect colon or rectal cancers — but it also raised some concerns, NBC News reported May 23.
FDA panel recommends approval of a blood test for colon cancer
NBC NEWS· 1 day agoIf approved, Shield could become the second blood-based test for colon cancer diagnosis in the...
US FDA panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients
AOL· 10 hours agoThe Food and Drug Administration's panel voted 7-to-4 against the use of the weekly basal insulin icodec saying its benefits do not outweigh the risks when used in adult patients with type 1 ...
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements
The National Law Review· 5 days agoOn May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly...
Novavax awaits FDA decision on whether its next COVID shot can be offered in US
Reuters· 11 hours ago, opens new tab will only be able to offer a COVID-19 vaccine in the United States this autumn if regulators accept the shot it has started manufacturing that targets a variant that was dominant ...
FDA OK’s Elon Musk’s Neuralink to implant brain chip into second patient: report
NY Post via Yahoo News· 5 days agoNews of the FDA’s approval was first reported by The Wall Street Journal on Monday. Neuralink has...
FDA withdraws Helsinn’s accelerated approval for cancer drug after company’s request
Endpoints News· 4 days agoThe FDA on Friday withdrew an accelerated approval for Helsinn’s bile duct cancer drug, two years...