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Human Drugs

Hi-Tech Pharma CEO Convicted in GMP Fraud Scheme

Government prosecutors win guilty conviction against Hi-Tech Pharmaceuticals CEO and twice-convicted felon Jared Wheat for orchestrating a years-long ...

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Human Drugs

FDA Safety Alert on Some BD Alaris Pump Modules

FDA issues a safety alert after Becton Dickinson recently recalled (Class 1 device correction) certain Alaris Pump Modules if they have been dropped o...

Biologics

Experts Criticize New FDA Vaccine Skepticism Memo

Leading vaccine experts sharply criticize a new FDA memo that claims ten children died after and because of receiving Covid-19 vaccines between 2021 a...

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Human Drugs

Positive Data in Stargardt Disease Pivotal Trial

Belite Bio reports positive topline results from the global Phase 3 DRAGON trial of tinlarebant, marking the first successful pivotal trial in patient...

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Human Drugs

FDA Deploys New AI Tool Under Efficiency Scheme

FDA says it has deployed advanced agentic AI capabilities to all agency employees, marking a major expansion of its artificial intelligence tools for ...

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FDA General

Guidance to Update Manufacturing Standards for Medical Gases

FDA posts a draft guidance outlining updated current good manufacturing practice standards for medical gases.

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Medical Devices

Glycar Recalls 1 Lot of SJM Pericardial Patch

Glycar recalls (Class 1) certain batches of the SJM Pericardial Patch because affected units may fail to meet required tensile-strength specifications...

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Human Drugs

MannKind sNDA for Rapid-Acting Furoscix Autoinjector

FDA accepts for review a MannKind supplemental NDA for its Furoscix ReadyFlow autoinjector, a fast-acting device designed to treat edema in adults wit...

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Human Drugs

Durvalumab Regimen OKd for Gastroesophageal Cancer

FDA approves AstraZenecas Imfinzi (durvalumab) in combination with chemotherapy as a perioperative treatment for adults with resectable gastric or gas...

Human Drugs

FDA Extends Review of TransCon CNP for Achondroplasia

FDA extends by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating children with achondroplasi...