FDA Accepts NDA with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST June 2, 2026
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours May 26, 2026
FDA Accepts Supplemental BLA for ANKTIVA + BCG in BCG-Unresponsive NMIBC with Papillary Disease; PDUFA Jan 2027 May 26, 2026
HREC Australia approves HLX3902 for Clinical Trial in Australia in metastatic CRPC and other advanced solid tumours May 26, 2026
Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1L advanced ER+ve breast cancer May 26, 2026
Successful Outcome of FDA Type C Meeting Request for HARMONIC Ph 2 Trial of LP-300 in Never-Smokers with NSCLC Announced May 26, 2026
Positive EU CHMP Opinion for KEYTRUDA + Padcev as Perioperative Treatment for Adults With Cisplatin-Ineligible Resectable MIBC May 26, 2026
Supplemental NDA submitted in Japan for PADCEV + Keytruda in Cisplatin-Eligible Patients with MIBC May 21, 2026
FDA Grants Priority Review to Supplemental NDA for HYRNUO® (sevabertinib) Under Investigation in 1L HER2-Mutated NSCLC May 21, 2026
NDA approval from NMPA CDE for Opamtistomig (LBL-024) to initiate Ph 3 trial for 1L EP-NEC May 21, 2026
Supplemental NDA for Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab in 1L PD-L1+ve NSCLC Accepted for Review by NMPA May 12, 2026
FDA cleared IND for Ph 1/2 study of oral elraglusib in metastatic melanoma, NSCLC, colorectal, and pancreatic cancers May 12, 2026
NICE issues Final Draft Guidance recommending RYBREVANT + chemo during managed access period in 1L NSCLC with EGFR ex20ins mutations in adults May 12, 2026
Protocol Amendment to NANORAY-312 Ph 3 Head and Neck Cancer Study of for JNJ-1900 (NBTXR3) Announced May 12, 2026
FDA Accepts Supplemental NDA for IBTROZI® (taletrectinib) with Updated DoR in Advanced ROS1+ve NSCLC May 12, 2026
FDA Commissioner’s National Priority Voucher for BIZENGRI® (Zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma May 12, 2026
