Shots:
The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.
Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).
Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
Shots:
The US FDA has approved AbbVie's Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with BPDCN
Approval was supported by the global P-I/II (CADENZA) trial in 84 pts with CD123+ hematologic malignancies, incl. BPDCN, where pts received Decnupaz in both frontline (n=33) & relapsed/refractory (R/R) settings (n=51) without active CNS disease
Trial reported a 69.7% composite…

