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Animal Drugs

Sarepta Seeking Gene Therapy Expanded Use

Sarepta Therapeutics says it will file a supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to expand the therapys use in all patients ...

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Human Drugs

GSK Jemperli Trial Meets Endpoint

GSK says a Phase 3 trial evaluating its Jemperli (dostarlimab) in adult patients with primary advanced or recurrent endometrial cancer met its primary...

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Human Drugs

Novartis Seeks Accelerated OK for IgAN Drug

Novartis says it will seek FDA accelerated approval for atrasentan and its use in treating patients with IgA nephropathy.

Medical Devices

Impulse Dynamics Heart Device OKd for MRI

FDA approves Impulse Dynamics Optimizer Smart Mini system for whole-body MRI-conditional use.

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Human Drugs

Deciphera Pharma Planning NDA for Vimseltinib

Deciphera Pharmaceuticals says it will file an NDA in the second quarter of 2024 for vimseltinib for treating patients with tenosynovial giant cell tu...

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Human Drugs

Lillys Ulcerative Colitis Therapy Approved

FDA approves an Eli Lilly BLA for Omvoh (mirikizumab-mrkz) infusion, described as the first interleukin-23p19 (IL-23p19) antagonist for treating moder...

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Human Drugs

TX Man Gets 5 Years Over Unapproved Drugs

A federal court in Texas sentences Evan Asher Field to five years in prison for selling unapproved drugs through the mail.

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Human Drugs

Vabysmo OKd for Retinal Vein Occlusion Edema

FDA approves Genentechs Vabysmo (faricimab-svoa) for treating macular edema following retinal vein occlusion.

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Human Drugs

Sickle Cell Therapy Safety Assessment Questioned

FDA reviewers plan to ask an advisory committee 10/31 whether Vertex Pharmaceuticals and CRISPR Therapeutics need to conduct additional studies on the...

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Human Drugs

Bill to Reduce Dependence on China Drugs

Senator Marco Rubio introduces a bill entitled Further Strengthening Americas Supply Chains and National Security Act to reduce Americas dependence on...