March 26, 2026 at 11:47PM FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I

The U.S. Food and Drug Administration today approved Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I).

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March 26, 2026 at 12:57PM CASGEVY

CASGEVY indicated for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso occlusive crises (VOCs).

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Wednesday, March 25, 2026

March 26, 2026 at 03:00AM GAMMAGARD LIQUID

Product approval information is indicated for:
• Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
• Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

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Tuesday, March 24, 2026

March 24, 2026 at 08:15PM General Biologics Guidances

This page displays links to General Biologics Guidance documents.

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March 23, 2026 at 08:12PM Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot CL6814 through June 30, 2026

This is the Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot CL6814 through June 30, 2026

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March 24, 2026 at 01:01PM Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

Guidance for Industry and FDA Staff: Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

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Monday, March 23, 2026

March 23, 2026 at 04:42PM FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary

FDA-TRACK: Biosimilar User Fee Act Procedural Notification Goals Summary

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