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Guardant Health Stock Jumps. Blood Test for Cancer Moves Toward FDA Approval.
Barrons.com· 1 day agoShares of Guardant Health were rising sharply after the cancer company said a Food and Drug...
Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell...
BioresearchOnline· 2 days agoIn April 2024, the U.S. FDA released the draft guidance for industry Considerations for the Use of...
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 ...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 4 days agoOn May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration ...
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...
US FDA panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients
AOL· 21 hours agoNovo is aiming to be the first to hit the market with a weekly insulin product, offering an alternative for patients with type 1 and type 2 diabetes who now depend on multiple daily injections ...
Blood test to detect colon cancer could move a step closer to FDA approval in the US
KHBS - KHOG Fort Smith - Fayetteville· 2 days agoFood and Drug Administration approval of Shield, its blood test to screen for early signs of...
Indica Labs’ HALO AP Dx platform receives FDA 510(k) clearance
Medical Device Network via Yahoo Finance· 2 days agoIndica Labs has received 510(k) clearance from the US Food and Drug Administration (FDA) for its...
FDA cancer lead Harpreet Singh departs to serve as Precision for Medicine CMO
FierceBiotech· 2 days agoFDA oncology division director Harpreet Singh, M.D., has left the agency to join Precision for...
FDA approves belimumab autoinjector for pediatric systemic lupus erythematosus
Medical Xpress· 2 days agoThe U.S. Food and Drug Administration has approved GlaxoSmithKline's 200-mg subcutaneous route of...