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FDA to Scrutinize AI-Powered Mental Health Devices

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FDA schedules an 11/6 Digital Health Advisory Committee meeting to examine the rise of generative artificial intelligence in digit...

Capsida Pauses Gene Therapy Trial After Death

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Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 ...

Prasad Reassumes Chief Medical/Scientific Officer Role

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FDA commissioner Marty Makary reinstates CBER director Vinay Prasads previous additional duties as the agencys chief medical and s...

Non-Opioid Analgesic Development Guidance

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FDA publishes a draft guidance to assist in developing non-opioid analgesics to treat chronic pain.

Apollo TMS Cleared for Depressed Adolescents

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FDA clears a new indication for neurocare groups Apollo TMS therapy device to treat adolescents with major depressive disorder.

FDA Approves J&Js New Bladder Cancer Therapy

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FDA approves a Johnson & Johnson NDA for Inlexzo (gemcitabine intravesical system) for adults with non-muscle invasive bladder can...

Greenwich Gets Fast Track for Breast Cancer Therapy

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FDA grants Greenwich LifeSciences fast track status for GLSI-100 for preventing breast cancer recurrences.

FDA Orders Crackdown on Misleading Prescription Drug Ads

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In a new crackdown on drug advertising, FDA orders pharmaceutical companies to remove any noncompliant ads and bring all promotion...

FDA Digital Health Leader Leaves for Mayo Clinic

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Former FDA Digital Health Center of Excellence acting director Sonja Fulmer leaves the agency to accept a position at Mayo Clinic ...

Expanded Approval for AZs Koselugo

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FDA approves an expanded indication to include pediatric patients aged one and older for AstraZenecas Koselugo to treat some cases...