FDA Approval

Clinical Trials Medical Devices Drug Safety Drug Applications Drug Regulations Drug Approval Process Prescription Products Drug Regulation Drug Evaluation Clinical Development Medical Device Clearance Drug Development

15 ARTICLES

last mo.

FDA Approves Two First-in-Class Oral Treatments for Gonorrhea

The decisions introduce new mechanisms after years of reliance on ceftriaxone, with use restrictions and safety precautions designed to guide stewardship.

4 ARTICLES

last mo.

Roivant’s Brepocitinib Succeeds in 52-Week Dermatomyositis Phase 3 as Companies Target 2026 FDA Filing

FDA Approval

FDA Approves Two First-in-Class Oral Treatments for Gonorrhea

Daré Bioscience Launches Topical Sildenafil Cream for Female Arousal

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

FDA Approves Palsonify, First Once-Daily Oral Treatment for Acromegaly

Roivant’s Brepocitinib Succeeds in 52-Week Dermatomyositis Phase 3 as Companies Target 2026 FDA Filing