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Regulatory Daily Summary

Regulatory Daily Summary: What Happened on October 22, 2026

Europe approves Keytruda-Padcev before and after bladder cancer surgery

Scotland accepted atogepant for some adults with acute migraine, while H-1B changes continue to affect biopharma hiring.

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Today in brief

The European Commission approved MSD’s Keytruda-Padcev combination for adults with resectable muscle-invasive bladder cancer, given before and after surgery.1 The authorization covers patients regardless of cisplatin eligibility in the EU’s 27 member states, Iceland, Liechtenstein and Norway.1

Scotland accepted AbbVie’s atogepant for acute migraine in adults who have not had adequate relief, or cannot use or tolerate, at least two triptans, and have insufficient relief from NSAIDs and paracetamol.2

EU approves Keytruda-Padcev around bladder cancer surgery

The European Commission authorized MSD’s Keytruda and Padcev for adults with resectable muscle-invasive bladder cancer. Patients receive treatment before radical cystectomy and continue it after surgery.1 The approval includes Keytruda SC and applies regardless of cisplatin eligibility across the 27 EU member states, Iceland, Liechtenstein and Norway.1

In the randomized, open-label Phase 3 KEYNOTE-B15 study, also known as EV-304, the perioperative regimen cut the risk of recurrence, progression or death by 47% compared with chemotherapy and surgery.1 Among 808 patients, the combination reduced mortality risk by 35%. Pathologic complete responses occurred in 55.8% of patients on the regimen and 32.5% on chemotherapy.1 MSD said availability across Europe will depend on national reimbursement processes.1

Also worth knowing

  • A $100,000 fee for new H-1B petitions, extended through September 21, 2027, and proposed visa changes are affecting biopharma hiring. Two federal judges blocked the fee, and properly submitted registrations fell 38.5%, from 343,981 in fiscal 2026 to 211,600 in fiscal 2027.3

  • The FDA cleared Lynch Regenerative Medicine to begin a Phase 2 trial of injectable rhPDGF-BB for infraorbital hollowing. Primary safety and appearance-scale assessments are scheduled for 12 weeks.4