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Breaking: FDA authorizes second patient for Elon Musk's Neuralink brain chip trial | Invezz
Invezz· 6 days agoThe United States Food and Drug Administration (FDA) has authorized a second patient for Neuralink’s...
With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals
BioPharma Dive via Yahoo Finance· 2 days agoBut the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening...
Guardant wins FDA AdCom backing for colon cancer test
Medical Device Network via Yahoo Finance· 2 days agoDespite concerns over false negative results, the Medical Devices Advisory Committee (AdCom) for the...
Blood test to detect colon cancer could move a step closer to FDA approval in the US
ABC 7 Chicago· 3 days agoPalo Alto, California-based biotechnology company Guardant Health has applied for US Food and Drug ...
Amphastar Receives FDA Approval for Albuterol Sulfate Inhalation Aerosol
Morningstar· 4 days ago(NASDAQ:AMPH) today announced that the U.S. Food and Drug Administration ("FDA") has granted approval for the Company's Abbreviated New ...
FDA grants approval for two Eylea biosimilars for eye conditions
Pharmaceutical Technology via Yahoo Finance· 5 days agoThe US Food and Drug Administration (FDA) has approved Yesafili (aflibercept-jbvf) and Opuviz...
Advisory Panel Votes Against Once-Weekly Insulin for T1D
Medscape· 23 hours agoIn a 7 to 4 vote, an advisory panel to the US Food and Drug Administration (FDA) determined that the...
US FDA approves two biosimilars for blockbuster eye drug Eylea
AOL· 6 days agoThe agency approved Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, while also allowing interchangeability, or the drug's substitution with biosimilars ...
FDA approves CorTec’s implant system for stroke rehabilitation study
Medical Device Network via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has granted approval for an investigational device...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 5 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 ...