Weekly Digest – October 2026 Weekly Digest – October 2026 07 October 2026: AbbVie’s Temab-A receives FDA Breakthrough Therapy Designations for CRC and NSCLC AbbVie announced that the U.S. FDA has granted two Breakthrough Therapy Designations to Telisotuzumab adizutecan, its […]
Weekly Digest – October 2026 Weekly Digest – October 2026 08 October 2026: [²¹²Pb]PSV359 receives FDA Fast Track Designation for FAP-positive solitary fibrous tumors Perspective Therapeutics has received U.S. FDA Fast Track Designation for [²¹²Pb]PSV359 for adults with locally advanced […]
Weekly Digest – October 2026 Weekly Digest – October 2026 05 October 2026: Crescent Biopharma receives FDA IND clearance for CR-002 in Solid tumors Crescent Biopharma announced that the U.S. FDA has cleared the Investigational New Drug application for CR-002, […]
Weekly Digest – October 2026 Weekly Digest – October 2026 25 September 2026: Perioperative Imfinzi plus Enfortumab vedotin received U.S. FDA Priority Review for MIBC AstraZeneca announced that the U.S. FDA has accepted supplemental Biologics License Application for Imfinzi in […]
Weekly Digest – October 2026 Weekly Digest – October 2026 28 September 2026: BL-M05D1 received BTD in China for previously treated advanced Gastric/GEJ cancer Biokin Pharma announced that BL-M05D1, its Claudin18.2-directed ADC, has been included in China’s NMPA Breakthrough Therapy […]
Weekly Digest – October 2026 Weekly Digest – October 2026 25 September 2026: Ifinatamab deruxtecan BLA for previously treated extensive-stage SCLC was voluntarily withdrawn in the U.S. Daiichi Sankyo and MSD announced the voluntary withdrawal of the U.S. BLA seeking […]
Weekly Digest – September 2026 Weekly Digest – September 2026 18 September 2026: Enhertu receives CHMP recommendation for adjuvant treatment of HER2-positive early Breast cancer Daiichi Sankyo and AstraZeneca announced that Enhertu has been recommended by the EMA’s CHMP for […]
Weekly Digest – September 2026 Weekly Digest – September 2026 18 September 2026: PADCEV + Keytruda receives positive CHMP opinion for resectable MIBC Astellas and MSD announced that PADCEV in combination with KEYTRUDA received a positive CHMP opinion for perioperative […]
Weekly Digest – September 2026 Weekly Digest – September 2026 23 September 2026: SOTIO advances SOT106 with dual FDA designations for Sarcoma SOTIO announced that SOT106 received two additional FDA designations: Orphan Drug Designation for soft tissue sarcoma and Fast […]
Weekly Digest – September 2026 Weekly Digest – September 2026 22 September 2026: Iza-bren granted BTD in China for the treatment of mTNBC Biokin announced that Iza-bren, its first-in-class EGFR×HER3 bispecific ADC, has received China NMPA Breakthrough Therapy Designation for […]
