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FDA Clears Bright Uros Urodynamics Device

[ Price : $8.95]

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

Mirum Pharmaceuticals Livmarli Tablet Formulation OKd

[ Price : $8.95]

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

Ironwood Needs Another Apraglutide Trial: FDA

[ Price : $8.95]

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

Pfizer Nixes Oral Weight Loss Drug Development

[ Price : $8.95]

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

FDA Seizes Counterfeit Ozempic in Supply Chain

[ Price : $8.95]

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

Vanda Sues FDA to Allow Off-Label Promotion

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Vanda Pharmaceuticals sues FDA seeking a declaratory judgment giving the company protection under the First Amendment to promote H...

Marks Warns of Growing Anti-Vaccine Stance

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

Self-Inject Vyvgart Hytrulo Approved

[ Price : $8.95]

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

Fast Track for H5N1 Flu mRNA Vaccine

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

FDA OKs Opdivo + Yervoy in Liver Cancer

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FDA approves Bristol Myers Squibbs Opdivo (nivolumab) and Yervoy (ipilimumab) for combination first-line treatment of adult patien...