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Human Drugs

FDA Cant Locate UK Maker of Filthy Eye Drops

FDA fails to locate the UK-based manufacturer of filthy eye drops, LightEyez, accused of manufacturing and distributing unapproved and adulterated ove...

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Human Drugs

FDA Warns 2 Ophthalmic Drug Companies

FDA warns Mamaroneck, NY-based Delsam Pharma, and Lakewood, NJ-based EzriCare about distributing adulterated and misbranded ophthalmic products obtain...

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Human Drugs

FDA Denies BI Parenteral Drug Petition

FDA denies a Boehringer Ingelheim petition asking it to change its interpretation of strength for parenteral solutions under the Biologic Price Compet...

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Human Drugs

Technical Guide on Reporting Drug Amounts

FDA posts a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.

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Human Drugs

FDA Upping Drug Inspections in India: McMullen

FDA India director Sarah McMullen says the agency is working to increase drug inspections in India and station additional investigators there.

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Human Drugs

Viking Reports Favorable Trial, Data on Obesity Drug

Viking Therapeutics says its Phase 2 clinical trial of obesity drug VK2735, a dual agonist of glucagon-like peptide 1 and glucose-dependent insulinotr...

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Medical Devices

Alert Issued on Hologics BioZorb Markers

FDA issues a safety alert advising patients and healthcare providers about the potential risk of serious complications with Holigics BioZorb Marker an...

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Human Drugs

Wide Range of Rare Pediatric Treatments Developed

FDA researchers say a wide range of treatments for rare pediatric diseases have been developed in the 10 years since the pediatric disease priority re...

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Biologics

BeiGene BLA Filed for Gastric Cancer

FDA accepts for review a BeiGene BLA for Tevimbra (tislelizumab) for combination use with chemotherapy in treating locally advanced unresectable or me...

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Human Drugs

Complete Response Issued on Minerva Schizophrenia Drug

FDA sends Minerva Neurosciences a complete response letter on its NDA for roluperidone, indicated for treating negative symptoms in patients with schi...