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Human Drugs

Non-Penicillin Beta-Lactam Drug Guidance

FDA publishes a draft revising a 2013 guidance on a CGMP framework for preventing cross-contamination in non-penicillin beta-lactam drugs.

Medical Devices

Baxter Volara System Recall is Class 1

FDA says the Baxter Healthcare recall of its Volara system due to risk of respiratory distress in home use is Class 1.

Human Drugs

Court Approves Edge Pharm Injunction

The Vermont federal court approves a consent decree of permanent injunction against Colchester, VT-based Edge Pharm, a compound pharmacy accused of ma...

Medical Devices

FDA Clears Medtronic LigaPASS

FDA clears the Medtronic LigaPASS ligament augmentation system.

Human Drugs

Expanded Indication for Mercks Vaxneuvance

FDA approves an expanded indication for Mercks Vaxneuvance (pneumococcal 15-valent conjugate vaccine) to include children six weeks through 17 years o...

Human Drugs

Draft New Compounding MOU: Association Exec

Alliance for Pharmacy Compounding CEO Scott Brunner calls on FDA to abandon current efforts to draft a drug compounding memorandum of understanding wi...

Human Drugs

CURE ID App Updated

FDA and the National Center for Advancing Translational Sciences update the CURE ID crowd-sourcing drug repurposing app.

Human Drugs

Progress Being Made in Lung Cancer Therapies: Analysis

The LUNGevity Foundation says many lung cancer therapies are in development, including some relying on biomarkers.

Human Drugs

Mustang Bio Gets Orphan Status for CAR T Cell Therapy

FDA grants Mustang Bio an orphan drug designation for MB-106, a CD20-targeted, autologous CAR T cell therapy for treating Waldenstrom macroglobulinemi...

Human Drugs

Senators Unveil Legislation to Help with Insulin Costs

U.S. Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) reveal bipartisan legislation entitled Improving Needed Safeguards for Users of Lifesavin...