<속보>(기사 작성중) 카프리코(Capricor), “FDA가 데라미오셀(Deramiocel)의 심사 완료일을 3개월 늦췄다”(The FDA delayed the completion of the review for Deramiocel by three months)고 발표… 논란 속 기한 연장이 데라미오셀을 살려 낼까?
2026-08-27
FDA, ‘근육층까지 번진 방광암’에 백금계 항암제 없는, 수술 전후 치료 승인(FDA Approves Pre- and Post-Surgical Treatment Without Platinum-Based Chemotherapy for ‘Bladder Cancer That Has Spread to the Muscle Layer’)… 머크(Merck), 아스텔라스(Astellas), 화이자(Pfizer) 3사 공동 개발한 ‘병용 요법'(Combination Therapy)
On July 10, 2026, the FDA approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer[Read More…]
