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Heuron’s AI solution for stroke triage receives FDA clearance
Medical Device Network via Yahoo Finance· 2 days agoSouth Korean medical AI startup Heuron has obtained 510(k) clearance from the US Food and Drug ...
Biocon Biologics gets US FDA nod for biosimilar version of eye treatment drug Eylea
Investing.com· 5 days agoBiocon Biologics gets US FDA nod for biosimilar version of eye treatment drug Eylea
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...
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...
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...
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 ...
US FDA approves two biosimilars for blockbuster eye drug Eylea
Reuters via AOL· 6 days agoThe agency approved Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, while...
FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance | JD Supra
JD Supra· 4 days agoWhile the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign ...
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 ...
Guardant Health Jumps — As Exact Sciences Slumps — On A Key FDA Move For Blood Tests
Investor's Business Daily· 2 days agoGuardant Health stock jumped Friday after a Food and Drug Administration panel recommended the...