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Otsuka/Lundbeck sNDA for Alzheimers Agitation

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FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for brexpiprazole for use in treating ag...

Panel Meeting on Non-Rx Narcan

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Federal Register notice: FDA announces a 2/15 advisory committee meeting to discuss an Emergent BioSolutions supplemental NDA for ...

CardiacSense Vital Signs Watch Cleared by FDA

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FDA clears a CardiacSense 510(k) for its CSF-3 Watch for monitoring vital signs, such as electrocardiogram, beat-by-beat heart rat...

CDER Dismisses 26% Drop in 2022 Drug Approvals

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CDER dismisses any concern over the 26% drop in NDAs/BLAs approved in 2022, which saw approvals decline from 50 in 2021 to 37 last...

BioMarin Filing Additional Data for Hemophilia Gene Therapy

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BioMarin Pharmaceutical says it is submitting to FDA additional long-term data (three years) as part of the ongoing BLA review for...

Troubled Zyno Pays $493K over False Claims

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Zyno Medical agrees to pay $493,000 to resolve allegations that it violated the False Claims Act by causing the submission of clai...

FDA Publishes 5 Device Classification Notices

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FDA posts five device classifications that were requested under the agencys de novo program.

Law Extends Product Info Sharing Safe Harbor to Devices

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The recent omnibus legislation extends a drug company safe harbor to medical device companies on sharing health care economic info...

Evusheld May Not Neutralize New Covid Variant: FDA

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An FDA update says AstraZenecas Evusheld may not neutralize the new Covid-19 variant XBB.1.5.

FDA Hits Ipsen with Complete Response on Palovarotene

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FDA issues Ipsen Biopharmaceuticals a complete response letter on its NDA for palovarotene, an investigational treatment for reduc...