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Federal Register

HHS Withdraws SUNSET Final Rule

Federal Register notice: Health and Human Services withdraws a final rule entitled Securing Updated and Necessary Statutory Evaluations Timely (SUNSET...

FDA General

Senate Unveils User Fee Reauthorization Bill With FDA Enhancements

The Senate Health, Education, Labor and Pensions Committee introduces a bill to reauthorize FDAs user fee programs in addition to provisions to streng...

Medical Devices

ArjoHuntleigh Polska Recalls Floor Lifts

ArjoHuntleigh Polska recalls its Sara Plus floor lift following several complaints of smoke or flames coming out of the device.

Federal Register

Guide on Prostate Cancer Drug Development

Federal Register notice: FDA makes available a final guidance entitled Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues....

Human Drugs

FDA Extends Shelf Life for Lillys Bentelovimab

FDA extends the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is cur...

Medical Devices

FDA Approves Medtronic In.Pact 018 Balloon Catheter

FDA approves Medtronics In.Pact 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, indicated for the interventional treatme...

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.