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FDA Cant Locate UK Maker of Filthy Eye Drops

[ Price : $8.95]

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

FDA Warns 2 Ophthalmic Drug Companies

[ Price : $8.95]

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

FDA Denies BI Parenteral Drug Petition

[ Price : $8.95]

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

Technical Guide on Reporting Drug Amounts

[ Price : $8.95]

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

FDA Upping Drug Inspections in India: McMullen

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

Viking Reports Favorable Trial, Data on Obesity Drug

[ Price : $8.95]

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

Alert Issued on Hologics BioZorb Markers

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FDA issues a safety alert advising patients and healthcare providers about the potential risk of serious complications with Holigi...

Wide Range of Rare Pediatric Treatments Developed

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

BeiGene BLA Filed for Gastric Cancer

[ Price : $8.95]

FDA accepts for review a BeiGene BLA for Tevimbra (tislelizumab) for combination use with chemotherapy in treating locally advance...

Complete Response Issued on Minerva Schizophrenia Drug

[ Price : $8.95]

FDA sends Minerva Neurosciences a complete response letter on its NDA for roluperidone, indicated for treating negative symptoms i...