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,…

ByDipanshu Dixit1 hour ago

Shionogi Secures US FDA Approval of Xocova for PEP COVID-19 Prevention

Shots: The US FDA has approved Xocova (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents (age≥12 yrs) following exposure to a person with COVID-19 Approval was based on a global P-III (SCORPIO-PEP) trial in 2,387 participants aged ≥12 yrs exposed to a household member with symptomatic COVID-19. The primary analysis included 2,041 SARS-CoV-2-negative participants who received Xocova (n=1,030; 375 mg on…

ByDipanshu DixitMay 29, 2026

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Shots: The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in Taiwan, Japan (for both PEP & paediatric pts), & the EU NDA was supported by global P-III (SCORPIO-PEP) trial assessing ensitrelvir vs PBO as post-exposure…

ByRidhi RastogiSeptember 3, 2025

The US FDA New Drug Approvals in May 2026

Shionogi Secures US FDA Approval of Xocova for PEP COVID-19 Prevention

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Contact US

FOLLOW US