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US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters via Yahoo News· 4 days agoThe reviewers, however, said the test may increase compliance with screening for colorectal cancer...
Mirat Shah, MD, on Elacestrant's FDA Approval for Breast Cancer With ESR1 Mutations
MedPage Today· 4 days agoFDA scientists published a detailed rationale for the approval of elacestrant (Orserdu), the first...
Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell...
BioresearchOnline· 3 days agoIn April 2024, the U.S. FDA released the draft guidance for industry Considerations for the Use of...
Novavax awaits FDA decision on whether its next COVID shot can be offered in US
Stars and Stripes· 17 hours agoNovavax 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 earlier ...
US FDA panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients By Reuters
Investing.com· 1 day agoNovo is aiming to be the first to hit the market with a weekly insulin product, offering an...
FDA panel recommends approval of a blood test for colon cancer
NBC NEWS· 2 days agoIf approved, Shield could become the second blood-based test for colon cancer diagnosis in the...
Blood test to detect colon cancer could move a step closer to FDA approval in the US
KOCO 5 Oklahoma City· 2 days agoFood and Drug Administration approval of Shield, its blood test to screen for early signs of...
FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance | JD Supra
JD Supra· 4 days agoThe FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device ...
Exact Sciences stock drops as Guardant Health test supported by FDA panel
Investing.com· 2 days agoExact Sciences stock drops as Guardant Health test supported by FDA panel
FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men
North Denver News· 2 days 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 ...