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Fast Track for Pfizer Investigational Combination Drug

[ Price : $8.95]

FDA grants fast track designation for Pfizers ervogastat/clesacostat combination drug being developed to treat non-alcoholic steat...

Tvardi Therapeutics Orphan Status for Pulmonary Fibrosis Drug

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FDA grants Tvardi Therapeutics an orphan drug designation for TTI-101 for treating idiopathic pulmonary fibrosis.

FDA Approves Tibsovo for Some New AML Cases

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FDA approves Serviers Tibsovo, indicated for treating some new acute myeloid leukemia cases, six weeks ahead of its goal date.

Reata NDA for Treating Friedreichs Ataxia

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FDA accepts for priority review a Reata Pharmaceuticals NDA for omaveloxolone for treating patients with Friedreichs ataxia.

Manchin, Braun Introduce Opioids Superiority Bill

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U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) introduce the Ensuring the FDA Fully Examines Clinical Trial Impact and Vit...

Researchers See Breakthrough Therapy Value in Cancer

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A Friends of Cancer Research-funded analysis shows a positive correlation between drugs receiving a breakthrough therapy designati...

OTC External Analgesic Product Labeling Petition

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Attorney Nancy Taylor asks FDA to take steps to increase the use of OTC external analgesics in pain management.

Abbott Dragonfly Catheter Recall is Class 1

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FDA says an Abbott recall of specific lots of its Dragonfly OpStar imaging catheter due to a potential loose marker band is Class ...

Panel to Review Skin Lesion AI Technology

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Federal Register notice: FDA announces a 7/28-29 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committ...

Info Collection on Device Postmarket Surveillance

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Federal Register notice: FDA seeks comments on an information collection extension entitled Postmarket Surveillance of Medical Dev...