Amgen gets expanded FDA label approval for Uplizna
Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...
BioMarin Pharmaceutical: Pegasus Success May Lead To Palynziq Label Expansion
BioMarin Pharmaceutical Inc. has advancements in phenylketonuria treatment. Click to learn how Palynziq's success could ...
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares ...
DEA Forces Marijuana Pharma Drug Industry Offshore: A Symbol of DEA Systemic Obstruction Against Trump Administration Directives
"The DEA's marijuana approach is stuck in an outdated ‘war on drugs' mentality," said Duane Boise CEO of MMJ International ...
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Sanofi: Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes ...
Endovascular Today9d
Vasorum’s Celt ACD Plus Vascular Closure Device Approved by FDA
Vasorum USA, Inc. announced FDA approval of the Celt ACD Plus system, which is designed for rapid arterial puncture closure ...
Zacks Investment Research on MSN9d
SLNO Stock Rallies on FDA Approval of Prader-Willi Syndrome Drug
Shares of Soleno Therapeutics SLNO have rallied 37% in the premarket hours today following the FDA approval of Vykat XR ...
MedTech Dive10d
Dexcom’s FDA warning letter reveals unauthorized changes to sensors
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
MarketWatch15d
Telix Pharmaceuticals' New Drug Application for Prostate Imaging Drug Gets FDA Approval
Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval. The Melbrourne, Australia-based biopharmaceutical company said Friday that the ...
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Glenmark Gets FDA Approval For Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)
(RTTNews) - Glenmark Pharmaceuticals Inc., USA announced that it has received final approval from the U.S. Food & Drug Administration (FDA) for its Olopatadine Hydrochloride Ophthalmic Solution ...
MarketWatch15d
Alnylam's Amvuttra Gets Approval for Expanded Indication From FDA
Alnylam Pharmaceuticals' amyloidosis drug Amvuttra received Food and Drug Administration approval for an expanded indication. The drug was approved for treatment of the cardiomyopathy of wild-type ...