Healthcare ❯ Regulatory Affairs

Drug Approval Process

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

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

The ruling follows phase 3 data showing longer survival with relacorilant plus nab-paclitaxel.

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