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Regulatory Approval

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5 ARTICLES

3mo ago

FDA Grants Accelerated Approval for RP1 (Tudriqev) With Nivolumab in Advanced Melanoma

The agency based its decision on response‑rate results from a single‑arm IGNYTE trial with continued approval contingent on an ongoing randomized confirmatory study.

3 ARTICLES

11mo ago

Agios’ Sickle Cell Pill Lifts Hemoglobin but Misses Pain-Crisis Goal in Phase 3

4 ARTICLES

11mo ago

UK Approves Once-Every-Four-Weeks IV Maintenance Dosing for Leqembi in Early Alzheimer’s

4 ARTICLES

last yr.

Indomo's ClearPen, an At-Home Acne Steroid Injector, Set for Phase 2 Trial Next Year

5 ARTICLES

last yr.

Hot-Glue-Gun Device 3D-Prints Bone Implants in Surgery With Promising Rabbit Results