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Amycretin Sees 14.5% Weight Loss in Phase 2 Diabetes Trial

[ Price : $8.95]

Novo Nordisk reports favorable Phase 2 data for its investigational dual-action obesity and diabetes drug amycretin, showing signi...

Study Finds Public Speaker Conflicts at FDA Panel Meetings

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A new study of FDA advisory committee meetings reveals that a substantial portion of public speakers support drug approval, and ma...

Catalent Indiana FDA-483 Has Six Observations

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FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana sterile drug manufacturing facility...

Democrat Lawmakers Probe FDA Voucher Program

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U.S. House and Senate health committee leaders express concern about a new FDA review pilot program because it appears designed to...

FDA Finds Sterility Lapses at NJ Drug Outsourcer

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FDA investigators cite Molecular PharmaGroup, an outsourcing facility in New Providence, N.J., for multiple sterility and quality-...

Alert on Misassembled Fresenius Infusion Pump Components

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FDA issues an early alert warning about a potentially high-risk defect in certain Fresenius Kabi Ivenix large volume pump primary ...

J&J Scraps Alzheimers Trial After Disappointing Data

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Johnson & Johnson discontinues its Auτonomy Phase 2b Alzheimers study after interim data showed its experimental antibody pos...

FDA Flags Misleading Promotion of Generic Ketamine Drug

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FDA cites PharmaTher over alleged misleading promotional claims for its generic ketamine.

Novo Nordisks Alzheimers Hopes Face Set Back

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Novo Nordisk says data from two global Phase 3 trials of semaglutide (Ozempic and Wegovy) have failed to slow clinical progression...

Woodcock Urges Stronger FDA Role in Updating Generic Labels

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Former FDA principal deputy commissioner Janet Woodcock and policy experts from Duke University call on the agency to adopt new to...