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Human Drugs

Researchers See Breakthrough Therapy Value in Cancer

A Friends of Cancer Research-funded analysis shows a positive correlation between drugs receiving a breakthrough therapy designation for non-small cel...

Human Drugs

OTC External Analgesic Product Labeling Petition

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

Medical Devices

Abbott Dragonfly Catheter Recall is Class 1

FDA says an Abbott recall of specific lots of its Dragonfly OpStar imaging catheter due to a potential loose marker band is Class 1.

Federal Register

Panel to Review Skin Lesion AI Technology

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

Federal Register

Info Collection on Device Postmarket Surveillance

Federal Register notice: FDA seeks comments on an information collection extension entitled Postmarket Surveillance of Medical Devices 21 CFR Part 82...

Medical Devices

FDA Approves ManaSport Ultrasound Therapy Device

FDA approves the ManaMed ManaSport Class 2 ultrasound therapy device for pain relief and soft-tissue injuries.

Human Drugs

Fast Track for Pfizer Investigational Combination Drug

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

Human Drugs

Tvardi Therapeutics Orphan Status for Pulmonary Fibrosis Drug

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

Human Drugs

FDA Approves Tibsovo for Some New AML Cases

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

Human Drugs

Reata NDA for Treating Friedreichs Ataxia

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