October 23, 2026
Drug Approvals
Evoxac® (cevimeline) oral solution – New formulation approval
October 20, 2026 - Cosette Pharmaceuticals announced the FDA approval of Evoxac (cevimeline) oral solution, for the treatment of symptoms of dry mouth in adults with Sjögren’s disease.
Drug Approvals
Hibsago (bepirovirsen) – New drug approval
October 20, 2026 - The FDA announced the approval of GSK’s Hibsago (bepirovirsen), in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis who have been on NrtI therapy for at least 6 months and have suppressed HBV DNA, and who have HBV surface antigen (HBsAg) levels less than or equal to 3,000 IU/mL as determined by an FDA-authorized test.
Clinical Updates
Anktiva® (nogapendekin alfa inbakicept-pmln) – Expanded indication
October 14, 2026 - The FDA announced the approval of Altor BioScience’s Anktiva (nogapendekin alfa inbakicept-pmln), in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).
Clinical Updates
Enspryng® (satralizumab-mwge) – New indication
October 15, 2026 - Genentech announced the FDA approval of Enspryng (satralizumab-mwge), for the treatment of thyroid eye disease (TED) regardless of TED activity or duration in adult patients.
Clinical Updates
Jemperli® (dostarlimab-gxly) – New indication
October 19, 2026 - The FDA announced the approval of GSK’s Jemperli (dostarlimab-gxly), as a single agent, for the treatment of adult patients with Stage II/III, locally advanced rectal cancer (LARC) that is microsatellite instability-high (MSI-H) or dMMR, as determined by an FDA-authorized test for solid tumors.
Ryzumvi® (phentolamine) – New indication
October 16, 2026 - Viatris announced the FDA approval of Ryzumvi (phentolamine), for the treatment of presbyopia in adults.