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Human Drugs

Groups Want Changes in Drug Labeling Guidance

Two drug company associations recommend changes to an FDA draft guidance on the content and format of labeling statements of ingredients in NDAs and A...

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Medical Devices

Magellan Guilty Plea Over Misbranded Devices

Magellan Diagnostics pleads guilty in federal court to criminal charges arising from its concealment of a device malfunction that produced inaccuratel...

Human Drugs

Carvykti Improves Survival in Phase 3 Trial: J&J

J&J touts positive overall survival results of its Carvykti in a Phase 3 trial in patients with relapsed or lenalidomide-refractory multiple myeloma a...

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FDA General

FDA WEBVIEW CLOSED JULY 4TH WEEK

In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 8.

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Human Drugs

Brookfield Medical/Surgical FDA-483

FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Supplies outsourcing f...

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Biologics

Complete Response on Rocket Gene Therapy

FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marne-cel) for treating ...

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Human Drugs

Shorla Oncology Breast/Ovarian Cancer Drug OKd

FDA approves a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer.

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Human Drugs

Promising Myasthenia Gravis Trial Data: J&J

Johnson & Johnson reports positive data from its Phase 3 Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.

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Human Drugs

Praise for Biological Labeling Draft Guidance

The Biosimilars Council and Biosimilars Forum praise a revised FDA draft guidance on biosimilar promotional labeling.

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Drug Delivery Device Guidance

FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery performance in device...