May 20, 2025

FDA Releases Guidance to Accelerate Generic Drugs

The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."

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May 20, 2025

Clinical Trials Missing in Half of AI Tools

Researchers analyzed FDA-approved AI-enabled medical devices and reported that clinical performance and subgroup data were frequently missing.

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May 19, 2025

Bacteria Eat, Exploit Plastic: Study 

A hospital-derived strain of Pseudomonas aeruginosa was found to degrade medical plastic, use it as food, and form stronger biofilms, revealing new risks for device-related infections.

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May 16, 2025

FDA Clears First Blood Test for Alzheimer’s

The FDA has cleared the first blood-based test to aid in diagnosing Alzheimer’s disease, offering a less invasive alternative to positron emission tomography scans and cerebrospinal fluid testing for cognitively impaired patients.

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May 16, 2025

FDA Approves PD-1–Targeted Monoclonal Antibody for SCAC

The FDA has approved Zynyz (retifanlimab-dlwr) as the first programmed death receptor-1 inhibitor for first-line treatment of advanced squamous cell carcinoma of the anal canal.

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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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