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Human Drugs

Rapid-Acting Depression Drug Gets Priority Review

FDA accepts for priority review a Biogen and Sage Therapeutics, NDA for zuranolone, a rapid-acting once daily oral drug for major depressive disorder ...

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Medical Devices

Group Seeks Clinical Decision Support Guide Rescission

A citizen petition from the Clinical Decision Support (CDS) Coalition urges FDA to rescind its controversial 9/2022 final guidance on Clinical Decisio...

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Human Drugs

MD Sentenced in Avanir Kickbacks

Former physician Deepak Raheja (Hudson, Ohio) gets 30 months in prison after pleading guilty to pharmaceutical kickback conspiracy charges involving t...

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Medical Devices

Abbott Expanded Indication for Ablation Catheter

FDA approves an Abbott expanded indication for its FlexAbility Ablation Catheter, Sensor Enabled, a flexible tip catheter intended to help physicians ...

Human Drugs

Tezspire Approved as Pre-filled Pen for Asthma

FDA approves AstraZeneca and Amgens asthma drug Tezspire (tezepelumab) in a self-administration pre-filled, single-use pen for patients aged 12 years ...

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Federal Register

Meeting on Developing Digital Health Technologies

Federal Register notice: FDA announces a 3/28-29 public workshop entitled Understanding Priorities for the Development of Digital Health Technologies ...

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Federal Register

Workshop on Generic Drug Science Initiatives

Federal Register notice: FDA announces a 5/11 public workshop entitled FY 2023 Generic Drug Science and Research Initiatives Workshop.

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Biologics

Sandoz Prolia/Xgeva Biosimilar BLA Submitted

FDA accepts for filing a Sandoz BLA for a biosimilar version of Amgens denosumab (Prolia and Xgeva), which includes all indications for the reference ...

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Medical Devices

Device Co. Pays $500K over False Claims: DoJ

Medical device manufacturer Joint Active Systems (Effingham, IL) agrees to pay $500,000 under a Justice Department settlement over False Claims Act vi...

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Human Drugs

Trodelvy OKd for Pre-treated Metastatic Breast Cancer

FDA approves a Gilead Sciences supplemental BLA for Trodelvy for treating certain adult patients breast cancer who have received endocrine-based thera...