May 05, 2025

FDA Monthly Round-up: Key April Updates

April’s FDA approvals feature first-in-class therapies, targeted biologics, expanded indications, and innovative delivery systems across allergy, endocrinology, rheumatology, oncology, infectious diseases, and more.

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April 30, 2025

New Phase III Data on Brensocatib Therapy

Phase III trial results show that once-daily brensocatib reduces pulmonary exacerbations and slows lung function decline in patients with bronchiectasis.

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April 25, 2025

FDA Approves Penpulimab-kcqx for NPC

The FDA approved penpulimab-kcqx for first line and previously treated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.

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April 03, 2025

New Option for IgA Nephropathy Management

The FDA has granted accelerated approval to Vanrafia (atrasentan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy who are at risk of rapid disease progression.

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March 21, 2025

Vutrisiran Receives FDA Nod for ATTR Amyloidosis With Cardiomyopathy

The FDA approves vutrisiran (Amvuttra) as the first RNAi therapeutic to reduce cardiovascular events and mortality in adults with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.

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April 01, 2025

FDA Approves Freeze-Dried Jynneos Vaccine

Bavarian Nordic’s freeze-dried Jynneos vaccine offers logistical advantages over the liquid-frozen version, supporting long-term U.S. stockpiling and public health preparedness.

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February 24, 2025

Game-Changer for Pfizer? Former FDA Drug Chief Takes Reins

Before leadership at the FDA, Dr. Patrizia Cavazzoni spent nearly 2 decades in the pharmaceutical industry.

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February 19, 2025

FDA Approves Amneal’s Lenalidomide; Mesalamine 800 mg Launched

Mesalamine 800 mg delayed-release tablets have been launched, and FDA approval has been granted for lenalidomide, with plans for entry into the U.S. generic market in 2026.

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April 04, 2025

First IgG4-RD Treatment Approved

A humanized monoclonal antibody that targets CD19+ B cells is first FDA-approved treatment for immunoglobulin G4–related disease, reducing flare risk and glucocorticoid use in clinical trials.

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