Healthcare ❯ Regulatory Affairs

Drug Approval Process

FDA FDA Designations Patent Implications U.S. Regulations China ANDA Vaccine Labeling Market Entry Strategies Clinical Trials Market Launch New Drug Application Therapeutic Goods Administration

Amylyx’s Avexitide Cuts Moderate‑to‑Severe Post‑Bariatric Hypoglycemia Events 55% in Phase 3

Amylyx plans a year‑end FDA filing that could lead to a 2027 launch funded by a new equity offering.

FDA Approves First Glucocorticoid Receptor Blocker for Platinum-Resistant Ovarian Cancer

Eli Lilly to Invest $3 Billion in China to Build Orforglipron Manufacturing

FDA Reapproves GSK’s Blenrep for Multiple Myeloma in Narrow Combination Use

ABIVAX to Present Late-Breaking Phase 3 Ulcerative Colitis Data on Oct. 6 at UEG Congress