Health ❯ Healthcare ❯ Pharmaceuticals ❯ Drug Approval

FDA Regulations

FDA Approves First All-Oral, Fixed-Duration First-Line CLL/SLL Regimen: Calquence Plus Venetoclax

The ruling rests on AMPLIFY Phase III results showing superior progression-free survival to chemoimmunotherapy.

FDA Sets Single-Study Default for New Drug Approvals

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

FDA Approves Wegovy Weight-Loss Pill as First Oral GLP-1 for Obesity

U.S. Strikes Price-Cut Deals With Novo Nordisk and Eli Lilly for GLP‑1s, With Medicare Pilot in 2026

Cytokinetics Investors Urged to Act as Lead‑Plaintiff Deadline Nears in REMS‑Related Securities Suit

Cytokinetics Faces Investor Class Action Over Aficamten REMS Disclosures as Lead-Plaintiff Deadline Nears