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Harvard Law Hits User Fees Over Corporate Capture

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A new analysis from Harvard Law School argues that the U.S. drug regulators reliance on industry-paid user fees has left the agenc...

Drug, Biologic Approvals Drop in 2025

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FDA approves 46 novel new drugs and 18 new biologics in 2025, fewer than in the previous two years, likely due to the staffing tur...

GSK Hepatitis B Drug Hits Trial Marks

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GSK says its investigational hepatitis B drug bepriovirsen met the primary endpoint in two pivotal Phase 3 trials, with regulatory...

Vanda Hetlioz sNDA Not Approvable, FDA Says

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FDA says it cant approve a Vanda sNDA for Hetlioz to treat jet lag disorder in its current form.

Moonlake Immunotherapeutics Plans BLA Submission

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Moonlake Immunotherapeutics says that, based on recommendations from a meeting with FDA, it will submit a BLA in the second half o...

CGMP Violations at Absolutely Natural

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FDA warns Melbourne, FL-based Absolutely Natural about CGMP violations in its production of finished drugs.

Makary Touts Less Oversight on Wearables

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FDA commissioner Marty Makary promotes limited regulatory scrutiny of many wearable devices and software tools, a significant poli...

Class 1 Abiomed Impella Correction

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FDA says the Abiomed 6/23/2025 correction to user instructions for its Automated Impella Controllers was Class 1.

Agebox Illegally Selling Unapproved iKids-Growth Drugs

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FDA warns Wilington, DE-based Agebox about selling misbranded unapproved new drugs.