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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...
US FDA staff flags risk of low blood sugar for Novo Nordisk’s weekly insulin
WSAU Wausau· 3 days ago(Reuters) - The U.S. Food and Drug Administration's (FDA) staff on Wednesday pointed to "notable...
FDA seeks AI tech to predict, detect Parkinson’s symptoms
MedTech Dive via Yahoo Finance· 4 days agoBy testing artificial intelligence and machine learning models, the agency hopes to come up with...
FDA approves first DLL3 × CD3 bispecific T-cell engager for lung cancer
Nature· 1 day agoDiscover the world’s best science and medicine | Nature.com
FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men
North Denver News· 1 day 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 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.
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...
Blood test to detect colon cancer could move a step closer to FDA approval in the US
ABC 7 Chicago· 2 days agoThe FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet...
FDA withdraws Helsinn’s accelerated approval for cancer drug after company’s request
Endpoints News· 5 days agoThe FDA on Friday withdrew an accelerated approval for Helsinn’s bile duct cancer drug, two years...
FDA signals potential shift toward interchangeability for all biosimilars | JD Supra
JD Supra· 1 day 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 ...