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Changes Sought to FDAs IT Strategy

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Three trade groups raise concerns and make suggestions for the FDA Information Technology Strategy.

FDA Should Develop Vision PRO Tool: AdvaMed

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The Advanced Medical Technology Association urges FDA to proceed with stakeholder recommendations to develop a central patient-rep...

FDA Warns on 26 Eye Drop Products

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FDA issues a warning on the use of 26 over-the-counter eye drop products due to the potential risk of eye infections that could re...

Sarepta Seeking Gene Therapy Expanded Use

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

GSK Jemperli Trial Meets Endpoint

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

Novartis Seeks Accelerated OK for IgAN Drug

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

Impulse Dynamics Heart Device OKd for MRI

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

Deciphera Pharma Planning NDA for Vimseltinib

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

Lillys Ulcerative Colitis Therapy Approved

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

TX Man Gets 5 Years Over Unapproved Drugs

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