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approval

Novo Nordisk snags high-dose Ozempic approval, turning up the heat on Lilly’s Trulicity

Novo Nordisk’s Ozempic, grappling with Eli Lilly’s Trulicity for supremacy of the GLP-1 diabetes market, hit a snag last year when the FDA refused to …

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approval

GlaxoSmithKline’s HIV drug Cabenuva scores FDA nod for 2-month dosing

Last January, when GlaxoSmithKline’s ViiV Healthcare won a long-awaited approval for its long-acting HIV treatment Cabenuva, it was hailed as a game-changer as it removed …

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approval

CStone’s PD-1 inhibitor CS1003 gets clinical trial approval in China

CStone will initiate a multi-center Phase I clinical trial to assess the safety, tolerability and preliminary anti-tumor activity of CS1003 in Chinese patients with advanced …

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anavex

Anavex Life Sciences Receives Approval To Initiate Phase 2b/3 Clinical Trial of ANAVEX®2-73 for the Treatment of Early Alzheimer’s Disease

ANAVEX®2-73 Being Studied as Potential First Precision Medicine Biomarker-guided, Targeted Therapeutic in Alzheimer’s Disease Primary and Secondary Endpoints measuring Safety, and Cognitive and Functional Efficacy …

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application

Invivoscribe Submits Pre-Market Approval Application in Japan and Panel Track Supplement in the US to Screen Acute Myeloid Leukemia (AML) Patients for FLT3 Mutations

Invivoscribe Technologies, Inc. announced today that they have submitted to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA) …

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approval

Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita® (burosumab-twza) for the Treatment of Children and Adults with X–Linked Hypophosphatemia (XLH)

First Approved Therapy for XLH in the U.S.; Only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease Ultragenyx to Host Conference …

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approval

Summit completes initial dosing trials on Duchenne muscular dystrophy drug

Summit Therapeutics has completed the half-way stage of dosing of its Duchenne Muscular Dystrophy (DMD) candidate ezutromid in a 48-week phase 2 trial, dubbed PhaseOut …

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