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Human Drugs

House GOPs Demand Clinical Data on Puberty Blockers

House Republicans demand the release of clinical data from taxpayer-funded research involving a study of puberty-blocking drugs that were not publishe...

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Federal Register

Info Collection on Antimicrobial Animal Drug Sales

Federal Register notice: FDA seeks comments on an information collection extension entitled Antimicrobial Animal Drug Sales and Distribution21 CFR 514...

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Human Drugs

Broader FDA Interpretations Needed for Review Vouchers: Hill

A bipartisan Congressional effort seeks broader FDA interpretations when awarding priority review vouchers.

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Human Drugs

FDA Sued Over Drug Compounding Restrictions

FarmaKeio Outsourcing, a drug compounding outfit, files a lawsuit against FDA seeking a court order to permit the compounding of sodium thiosulfate.

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Medical Devices

Medtronics Affera Mapping/Abalation Device Approved

FDA approves Medtronics Affera Mapping and Ablation System with Sphere-9 Catheter for treating persistent atrial fibrillation.

Animal Drugs

Animal Drug Regs Amended to Reflect Approvals

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug-related applications.

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Medical Devices

Kinova Recalls Wheelchair Robotic Arm

Kinova recalls (Class 1) its Jaco assistive robotic arm to correct the device due to an increased fire hazard.

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Medical Devices

Safety Alert on Hologics BioZorb Markers

FDA issues a safety alert recommending that healthcare providers not use BioZorb Markers and BioZorb LP Markers manufactured by Hologic.

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Human Drugs

Iterum Therapeutics Antibiotic OKd for UTIs

FDA approves an Iterum Therapeutics NDA for Orlynvah (sulopenem etzadroxil and probenecid) for treating certain uncomplicated urinary tract infections...

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Human Drugs

Orphan Status for Sickle Cell Disease Drug

FDA grants Kind Pharmaceutical an orphan drug designation for AND017 and its use in treating sickle cell disease.