May 29, 2026
Clinical Updates
Datroway® (datopotamab deruxtecan-dlnk) – New indication
May 22, 2026 - The FDA announced the approval of Daiichi Sankyo and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk), for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
Clinical Updates
Linzess® (linaclotide) – Expanded indication
May 21, 2026 - The FDA approved AbbVie’s Linzess (linaclotide), for the treatment of functional constipation (FC) in pediatric patients 2 years of age and older.
Drug Approvals
Differin® Epiduo® Acne Gel (adapalene/benzoyl peroxide) – New over-the-counter approval
May 22, 2026 - Galderma announced the FDA approval of over-the-counter (OTC) Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) 0.1%/2.5%.
Drug Approvals
Hepcludex® (bulevirtide-gmod) – New orphan drug approval
May 22, 2026 - The FDA announced the approval of Gilead’s Hepcludex (bulevirtide-gmod), for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.
Drug Recalls - Availability
Genentech – Discontinuation of Activase® (alteplase) 100 mg vial
May 21, 2026 - Genentech announced a business decision to discontinue Activase (alteplase) 100 mg vial. Activase is not being discontinued for reasons of safety or effectiveness.