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Novavax awaits FDA decision on whether its next COVID shot can be offered in US
Reuters· 4 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 ...
Market Today: Novo Nordisk Faces FDA Setback, Cathie Wood's Mark
Guru Focus· 1 hour agoThe S&P 500 (+0.7%) and Nasdaq Composite (+1.1%) closed at or near intraday highs, with the Nasdaq...
Guardant Soars On A Key Colon Cancer Win; Exact Sciences Dives
Investor's Business Daily· 11 hours agoThe FDA's Medical Devices Advisory Committee voted eight to one that Guardant's blood-based test,...
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
KSBW Salinas· 1 day agoFood and Drug Administration approval of Shield, its blood test to screen for early signs of...
FDA approves belimumab autoinjector for pediatric systemic lupus erythematosus
Medical Xpress· 1 day agoThe U.S. Food and Drug Administration has approved GlaxoSmithKline's 200-mg subcutaneous route of...
Guardant Health Colon Cancer Screening Test Backed by Majority Amidst Robust Debate in FDA Meeting
GenomeWeb News· 10 hours agoDuring the event, which highlighted the conclusions of an FDA-commissioned group tasked with evaluating Guardant Shield, a majority of panel members voted to recognize the ...
FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men
North Denver News· 20 hours agoAdvocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular, said they are frustrated the FDA hasn’t heeded their calls. Such groups have ...
FDA lifts partial clinical hold on Larimar’s Friedreich’s ataxia treatment
Endpoints News· 4 days agoLarimar Therapeutics’ stock $LRMR shot up by as much as 20% after announcing Monday that the FDA had...
FDA signals potential shift toward interchangeability for all biosimilars | JD Supra
JD Supra· 18 hours agoUnder the Biologics Price Competition and Innovation Act (BPCIA), a “biosimilar” product is one that is demonstrated to be “highly similar” to the reference product with “no clinically meaningful ...