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Medical Devices

FDA Clears Bright Uros Urodynamics Device

FDA clears a Bright Uro 510(k) for its Glean Urodynamics System, a wireless, catheter-free ambulatory urodynamics device designed to support clinical ...

Human Drugs

Mirum Pharmaceuticals Livmarli Tablet Formulation OKd

FDA approves Mirum Pharmaceuticals tablet formulation of Livmarli (maralixibat) for treating cholestatic pruritus.

FDA General

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Human Drugs

Ironwood Needs Another Apraglutide Trial: FDA

Based on FDA recommendation, Ironwood Pharmaceuticals says it will conduct a new Phase 3 clinical trial for apraglutide for treating short bowel syndr...

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Human Drugs

Pfizer Nixes Oral Weight Loss Drug Development

Pfizer abandons the development of danuglipron, an experimental oral GLP-1 receptor agonist being evaluated for chronic weight management, due to safe...

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Human Drugs

FDA Seizes Counterfeit Ozempic in Supply Chain

FDA seizes several hundred units of counterfeit Ozempic (semaglutide) 1mg injection that had entered the U.S. drug supply chain.

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Human Drugs

Vanda Sues FDA to Allow Off-Label Promotion

Vanda Pharmaceuticals sues FDA seeking a declaratory judgment giving the company protection under the First Amendment to promote Hetlioz (tasimelteon)...

Biologics

Marks Warns of Growing Anti-Vaccine Stance

Former CBER director Peter Marks tells Time that he was seeing an increasing anti-vaccine tone before he resigned from the agency over pressure from t...

Animal Drugs

Self-Inject Vyvgart Hytrulo Approved

FDA approves an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) f...

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Biologics

Fast Track for H5N1 Flu mRNA Vaccine

FDA grants Arcturus Therapeutics a fast-track designation for the self-amplifying mRNA vaccine candidate, ARCT-2304, for protecting against H5N1 influ...