Skip to content Skip to footer
Subscribe Now
INSIGHTS+

The US FDA New Drug Approvals in May 2026 

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,…
2 days ago

Read more

Astrazeneca
NEWS

AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Shots: The US FDA has approved AstraZeneca's Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment-resistant hypertension  Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension  Trial met…
May 18, 2026

Read more

Astrazeneca
NEWS

AstraZeneca Reports P-III (Bax24) Trial Data on Baxdrostat for Treatment-Resistant Hypertension

Shots: AstraZeneca has reported P-III (Bax24) trial data assessing baxdrostat (2mg; QD) + SoC vs PBO + SoC in 218 pts with treatment-resistant hypertension for 12wks. Trial achieved its 1EP, showing reduced 24hr. ambulatory systolic blood pressure at 12wks., with consistent efficacy across the day, incl. early morning; data to be presented at AHA’25 &…
October 7, 2025

Read more