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FDA approves CorTec’s implant system for stroke rehabilitation study
Medical Device Network via Yahoo Finance· 1 day agoThe US Food and Drug Administration (FDA) has granted approval for an investigational device...
House Members Question FDA Officials on Lab-Developed Tests, Missed Deadlines
MedPage Today· 3 days agoWith all the news about drug shortages, there's another type of possible shortage that the public...
2 Biotech Stocks to Buy in May
Motley Fool via Yahoo Finance· 3 hours agoIt reported positive results from a phase 3 study for a potential medicine for acute pain called suzetrigine. Vertex also initiated a rolling submission...
Guardant Health Stock Jumps. Blood Test for Cancer Moves Toward FDA Approval.
Barrons.com· 23 hours agoShares of Guardant Health were rising sharply after the cancer company said a Food and Drug...
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· 20 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
KOCO 5 Oklahoma City· 2 days agoFood and Drug Administration approval of Shield, its blood test to screen for early signs of...
Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell...
BioresearchOnline· 2 days agoIn April 2024, the U.S. FDA released the draft guidance for industry Considerations for the Use of...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 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 denies Ipsen's citizen petition for blockbuster drug Somatuline
Endpoints News· 24 hours agoUS drug regulators have turned down Ipsen’s effort to slow down generic competition for its blockbuster drug Somatuline Depot, which is used to slow the growth of some tumors as well as for ...