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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...

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...

Voucher Program Looks Like a Make-a-Deal Process: Experts

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Three Harvard medical professors raise concerns over FDAs review voucher program that they say could politicize drug approvals and...

FDA Posts Withdrawal Notice for Intercepts Ocaliva

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FDA posts a Federal Register notice finalizing the withdrawal of Intercept Pharmaceuticals Ocaliva (obeticholic acid) from the U.S...

FDA Issues Safety Notice on Nitric Oxide Delivery System

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FDA issues a correction notice for NOxBOX Ltd.s NOxBOXi Nitric Oxide Delivery System after reports of dosing fluctuations when the...

Keytruda/Padcev Combo OKd for Bladder Cancer

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FDA approves Mercks checkpoint inhibitor Keytruda (pembrolizumab) in combination with Astellas and Pfizers antibody drug conjugate...