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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...

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...

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.

3 Observations in Lonza Guangzhou FDA-483

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FDA releases the form FDA-483 with three observations from an inspection at Chinas Lonza Guangzhou Pharmaceutical active pharmaceu...

Esperion TV Spot for Nexlizet False, Misleading: FDA

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The CDER Office of Prescription Drug Promotion says an Esperion TV spot for Nexlizet falsely claims it is the only FDA-approved dr...

Petition Seeks Risk-Based Peptide Framework

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A biopharmaceutical expert petitions FDA to establish a risk-based regulatory framework for peptide therapeutics.