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FDA General

Rusfertide Phase 3 Data Meet Endpoints

Protagonist Therapeutics and Takeda report positive topline results for the Phase 3 VERIFY study that is evaluating rusfertide for treating polycythem...

Human Drugs

Lexicon Taps Pilavapadin 10mg for Phase 3

Lexicon Pharmaceuticals says it will advance pain drug pilavapadin 10mg into a planned Phase 3 trial based on just-announced Phase 2 PROGRESS study re...

EIRS/483s

PharmaTher Resubmits Ketamine NDA

PharmaTher also said it was working with its third-party manufacturing partner to resolve the deficiencies.

Medical Devices

Boston Scientific Recalls Pacemakers

Boston Scientific recalls its Accolade pacemakers and Visionist and Valitude cardiac resynchronization therapy pacemakers due to the possibility of th...

Medical Devices

Philips Recalls Tack Endovascular Device

Philips recalls its Tack Endovascular Systems due to customer complaints, including events where additional interventions were required to retrieve or...

Biologics

PhRMA Seeks Changes to Protocol Deviations Guide

Pharmaceutical Research and Manufacturers of America says FDA should make sure its recent draft guidance entitled Protocol Deviations for Clinical Inv...

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Medical Devices

Olympus Recalls Endoscope Guide Sheaths

Olympus recalls certain models of its endoscope single use guide sheath kits after receiving complaints about the radiopaque tip falling off into pati...

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Human Drugs

Labeling Changes for Testosterone Products: FDA

FDA orders testosterone product makers to change their drug labeling to remove a warning about risk of adverse cardiovascular outcomes in men.

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FDA General

Lawyers Say Government Shutdown Could Stall Reviews

FDAs ability to use its user fee carryover balances to fund product review operations during a potential government shutdown is unlikely because of se...

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Biologics

Odactra Approved for Expanded Use

FDA approves an ALK supplemental BLA for Odactra (house dust mite allergen tablet) to expand its use for treating house dust mite-induced allergic rhi...