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Federal Register

Heparin Sodium Not Withdrawn for Safety/Efficacy

Federal Register notice: FDA determines that a Fresenius Kabi NDA for heparin sodium injection was not withdrawn for reasons of safety or effectivenes...

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Medical Devices

Berlin Heart Recalls Excor Heart Pump

Germany-based Berlin Heart recalls its Excor Pediatric Ventricular Assist Device Blood Pumps due to the potential for therapy disruption.

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Human Drugs

Colorectal Cancer NDA Gets Priority Review

FDA accepts for priority review a Takeda and Hutchmed NDA for fruquintinib, indicated for treating adult patients with previously treated metastatic c...

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Medical Devices

Neuralink Says FDA OKs Brain Implant Trial

Elon Musks Neuralink says FDA has approved a human trial for its brain implant technology to be used to control external technology.

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Human Drugs

Lexicon Wins Approval for Heart Failure Drug

FDA approves a Lexicon Pharmaceuticals NDA for Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitaliz...

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Federal Register

Chirocaine Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Purdue Pharmas Chirocaine (levobupivacaine) injection was not withdrawn due to safety or effectiveness re...

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Human Drugs

Sitravatinib Fails in Phase 3 Lung Cancer Study

Mirati Therapeutics says its sitravatinib failed to meet the primary endpoint in the Phase 3 SAPPHIRE lung cancer study.

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Medical Devices

Power Morcellation Tissue Containment Guidance

FDA publishes a guidance with recommendations to help manufacturers comply with the special controls related to non-clinical performance data for gyne...

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Human Drugs

Trial Covariate Adjustment Guidance

FDA publishes a guidance with its recommendations on adjusting for covariates in the statistical analysis of randomized clinical trials in drug develo...

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Drug, Medical Device Recalls Up in 1st Quarter

The latest Sedgwick recall index report details increases in drug and medical device recalls in the first quarter of 2023 over the fourth quarter of 2...