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FDA Approves Merck’s ENFLONSIA™ to Prevent RSV in Infants

The Pharma Data

FDA Approves Merck’s ENFLONSIA™ to Protect Infants from Severe RSV Illness Merck operating as MSD outside the United States and Canada, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for ENFLONSIA™ (clesrovimab-cfor).

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FDA Approves Dupixent as First and Only Targeted Therapy for Bullous Pemphigoid in the US

The Pharma Data

FDA Approves Dupixent as the First and Only Targeted Therapy for Adults with Bullous Pemphigoid In a groundbreaking development for patients suffering from a rare and debilitating autoimmune skin disease, the U.S. This designation provides certain development incentives, including market exclusivity, tax credits, and fee waivers.

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U.S. FDA Grants Orphan Drug Designation to Riliprubart for Treating Antibody-Mediated Rejection in Solid Organ Transplant Recipients

The Pharma Data

The announcement is particularly relevant given the lack of FDA-approved treatment options for AMR, a complication that poses a critical threat to transplant success and long-term graft survival. These trials reflect Sanofi’s broad development program for riliprubart , which spans multiple rare and immune-mediated conditions.

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Sunvozertinib

New Drug Approvals

2] [4] Sunvozertinib was approved for medical use in the United States in July 2025. [1] 5] In China, it was conditionally approved in 2023 for the treatment of NSCLC and full approval is contingent on results of phase 3 clinical trials. [6] Sunvozertinib CAS 2370013-12-8 DZD9008, 584.1 12 (3): 217–224. PMID 38101437.

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Good things come in 3s

SugarCone Biotech

Two large and randomized clinical trials, IMpower-133 and CASPIAN, showing statistically significant improvements in outcomes when chemotherapy was combined with atezolizumab or durvalumab, respectively, in the first-line treatment of ES-SCLC. This Phase 3 trial compared tarlatamab with chemotherapy as second-line treatment.

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Gepirone

New Drug Approvals

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] The FDA rejected approval for gepirone in 2002 and 2004. [5] 1] It is taken orally.

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Pirtobrutinib

New Drug Approvals

7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] 4] The trial was conducted at 49 sites in 10 countries in the United States, Europe, Australia, and Asia. [6] 6] The same trial was used to assess safety and efficacy. [6]