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Canary Medical receives FDA breakthrough status for Lumbar Cartridge
Medical Device Network via Yahoo Finance· 21 hours agoFDA, an unparalleled accomplishment in our industry. “First, we received breakthrough designation...
FDA rolls out platform technology guidance to smooth future regulatory encounters
FierceBiotech· 18 hours agoTo speed up drug applications, the FDA has laid out new guidance on how to request a platform...
Dessert recall update as FDA issues new classification
Newsweek· 1 day agoThe Food and Drug Administration (FDA) has updated its previous recall of Mucci Food Product's...
Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance | JD Supra
JD Supra· 1 day agoIn newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development ...
Amgen Secures FDA Nod For Rare-Disease Treatment Biosimilar Based On AstraZeneca's Drug
Benzinga via Yahoo Finance· 1 day agoTuesday, the FDA approved Amgen Inc (NASDAQ:AMGN) Bkemv (eculizumab-aeeb) as the first...
FDA paves the way for reducing methane emissions from livestock
Environmental Defense Fund· 23 hours agoThis type of innovation is essential for slowing climate change. Lowering these emissions is essential for a safer climate, but until now, enteric methane solutions haven’t been available for ...
FDA fast tracks lung cancer treatment by Affimed By Investing.com
Investing.com· 1 day agoThe U.S. Food and Drug Administration (FDA) has granted Fast Track designation to a novel lung...
FDA Approves Nonstimulant Liquid Onyda XR for ADHD
Medscape· 1 day agoThe centrally acting alpha2-adrenergic agonist allows for nighttime dosing and can be used with stimulants, the drug's manufacturer says.
FDA approves interchangeable biosimilar to Soliris
Becker’s Hospital Review· 2 days agoThe FDA has approved Bkemv as the first interchangeable biosimilar to Soliris to treat certain rare diseases. Bkemv is approved for the treatment of patients with paroxysmal ...
FDA finalizes guidance on “Remanufacturing” vs “Servicing” | JD Supra
JD Supra· 23 hours agoIn contrast, servicing is “ the repair and/or preventive or routine maintenance of...specifications established by the OEM [original equipment manufacturer] and to meet its original intended ...
