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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

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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

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

Ex-FDA Lawyer Temkin Joins Paul Hastings

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Former FDA associate chief counsel and CDER policy advisor Eva A. Temkin joins Paul Hastings as chair of the firms FDA practice.

Vyaire Recalls Airlife Resuscitator

[ Price : $8.95]

Vyaire Medical recalls its AirLife Adult Manual Resuscitator and oxygen reservoir bag due to out-of-specification components used ...

Milestone Pharma Refiling Etrpamil NDA

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After receiving a 12/2023 FDA refuse-to-file letter, Milestone Pharmaceuticals now says it will resubmit the NDA in the second qua...