Health ❯ Regulatory Affairs

FDA Approval

Drug Approval Process Clinical Trials Drug Applications Drug Development Medical Devices Drug Evaluation Medical Device Clearance Clinical Development Health Monitoring Devices Drug Regulation Drug Products Drug Safety Drug Regulations Prescription Products Drug Dosage Clinical Trial Phases

Clearmind’s AUD Candidate Meets Early Safety Goal as Shares Double

The non-hallucinogenic MEAI pill advanced past the dose-escalation safety gate.

Lilly Launches FDA-Cleared Monthly Zepbound KwikPen on LillyDirect at $299 Starter Price

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