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FDA Probes New Death of Boy Who Got Elevidys

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FDA investigates another death of a young boy who received Sarepta Therapeutics gene therapy Elevidys for Duchenne muscular dystro...

Roche Reports Positive Data on Alzheimers Drug

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Roche announces new data on its Alzheimers therapy trontinemab and its plans to begin two Phase 3 clinical trials by the end of th...

House Reps Urge FDA Action on Counterfeit Obesity Drugs

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Bipartisan House lawmakers urge FDA to block counterfeit anti-obesity medications entering the U.S.

FDA Relents, Allows Gene Therapy Limited Use

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FDA reverses its enforcement stance against Sarepta Therapeutics and Duchenne Muscular Dystrophy gene therapy Elevidys after deter...

FDA Clears Stereotaxis MAGiC Sweep Catheter

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FDA clears a Stereotaxis 510(k) for its MAGiC Sweep catheter, a robotically navigated high-density electrophysiology mapping cathe...

Makary Defends CBERs Prasad After Loomer Attack

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FDA commissioner Marty Makary defends CBER director Vinay Prasad from recent criticism by Trump confidant Laura Loomer.

FDA Extends Review of Bayer Menopause Drug

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FDA extends by three months its review of a Bayer NDA for elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist for tr...

FDA/ASCO Unite on Oncology Optimal Dosing

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FDA and American Society of Clinical Oncology researchers urge drug makers to abandon outdated drug dosing strategies that are pot...

Edwards Lifesciences Recalls Arterial Perfusion Devices

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Edwards Lifesciences recalls (Class 1) its OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula after recei...

FDA Alert on Benzene Contamination in Products

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FDA issues an alert based on related to its ongoing investigation into the root causes of benzene contamination, calling on drug m...