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Draft Guide on Using AI for Drug Development

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FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-M...

Neumoras Phase 3 Depression Study Misses Endpoints

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Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary end...

CDER Approved 50 Novel Products Last Year

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CDER approves 50 novel products in 2024, five less than the 55 products approved in 2023 and well above the 10-year rolling annual...

FDA Alert on Boston Accolade Pacers Early Replacement

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FDA alerts patients, caregivers, and healthcare providers to the potential for some Boston Scientific Accolade pacemakers to need ...

FDA Approves Xcoverys Ensacove for Some Lung Cancers

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FDA approves Xcoverys Ensacove, an anaplastic lymphoma kinase inhibitor, to treat some non-small cell lung cancers.

FDA Approves Humacytes Symvess

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FDA approves Humacytes Symvess for use with some extremity arterial injuries.

FDA Wants Labeling Changes for Buprenorphine

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FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to ...

Global Unique Device ID Database Guidance

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FDA publishes an updated Global Unique Device Identification Database guidance.

FDA Approves Novo Hemophilia Prophylaxis Drug

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FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.

New Sleep Apnea Indication for Lillys Zepbound

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FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.