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FDA Regulations

FDA Approves First Gene Therapy for Inherited Hearing Loss

The ruling sets a precedent for inner-ear gene delivery that could spur more treatments.

FDA Clears Eli Lilly’s Foundayo Oral GLP-1 for Weight Loss, With U.S. Launch Set for April 6

FDA Clears Lilly’s Foundayo Pill, Escalating GLP-1 Weight-Loss Rivalry

FDA Approves Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

FDA Clears 7.2‑mg Wegovy as India Enters Generic Semaglutide Era

For Third Time, FDA Rejects Aldeyra’s Dry-Eye Drug Reproxalap Over Efficacy

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

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