09/04/2026 NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer Celltrion Wins Dual FDA Fast Track Approvals for ADC Pipeline Satri-cel: First CAR-T Therapy for Solid Tumors Set to Launch in China NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer ( Ref ) The New Drug Application (NDA) for DualityBio and BioNTech's DB-1303/BNT323 (Trastuzumab Pamirtecan, T-Pam; HER2‑targeted ADC) has been accepted by China’s National Medical Products Admini

08/04/2026 FDA Grants Orphan Drug Status to Plus Therapeutics’ REYOBIQ™ for Pediatric Malignant Gliomas FDA Grants Orphan Drug Designation to Compass Therapeutic’s Tovecimig for Biliary Tract Cancer FDA Grants Orphan Drug Status to Plus Therapeutics’ REYOBIQ™ for Pediatric Malignant Gliomas ( Ref ) Plus Therapeutics’ REYOBIQ™ (rhenium Re186 obisbemeda) has been granted orphan drug status for pediatric malignant gliomas, with scope expanded to include pediatric ependymoma Regu

April 1st Week, 2026 Regulatory Events   🎯 The EC approved Merck & Co./ MSD 's pembrolizumab (anti-PD-1) + paclitaxel ± bevacizumab for the Tx of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults with PD-L1 CPS ≥1, and who have received one or two prior systemic Tx regimens (Ref 1)  ❓ How is the regimen positioned in EU market landscape?   Special Designations    ⭐ The US FDA granted the breakthrough therapy designation to  Fore

07/04/2026 Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer Nuvalent Submits NDA for Neladalkib in ALK+ NSCLC NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer Corbus Gains FDA Alignment on CRB‑701 Registrational Trials in HNSCC and Cervical Cancer ( Ref ) Corbus reached broad agreement with the FDA on the registration path for CRB-701, a next-generation Nectin-4 targeting antibody-drug conjugate (ADC), i

Highlights from the CHMP Mar 2026 Meeting are out! New Medicines 💊  Ferring Pharmaceuticals ’ nadofaragene firadenovec gene therapy for the Tx of adults with BCG-unresponsive NMIBC with CIS with/without papillary tumours 💊  Amgen 's tarlatamab (DLL3 x CD3 BsAb) for the Tx of adults with ES-SCLC, who require systemic therapy following disease progression on or after 1L Tx with platinum-based chemo 💊  PharmaMar  &  Jazz Pharmaceuticals ' lurbinectedin (alkylating agent) + at

02/04/2026 Merck & Co./MSD's pembrolizumab + paclitaxel ± bevacizumab received the EC approval for Platinum-Resistant Recurrent Ovarian Carcinoma Context Therapeutics' CTIM-76 received the FDA fast track designation for platinum-resistant ovarian cancer AstraZeneca's Phase 3 EMERALD-3 trial met the PFS endpoint in embolisation-eligible unresectable HCC Merck & Co./MSD's pembrolizumab + paclitaxel ± bevacizumab received the EC approval for Platinum-Resistant Recurrent Ovarian