FDA & Government News

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.

Conexiant

May 06, 2025

FDA Approves TAVR Platform for Asymptomatic AS

The FDA has approved the SAPIEN 3 TAVR platform for patients with asymptomatic severe aortic stenosis based on data from the EARLY TAVR trial.

Conexiant

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.

Conexiant

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.

Conexiant

Mediastinitis Carries Highest Death Risk Postsurgery

FDA & Government News

FDA Approves PD-1–Targeted Monoclonal Antibody for SCAC

FDA Approves TAVR Platform for Asymptomatic AS

FDA Monthly Round-up: Key April Updates

FDA Approves Freeze-Dried Jynneos Vaccine

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Mediastinitis Carries Highest Death Risk Postsurgery

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