FDA Accepts NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC with Priority Review & PDUFA target action date of Nov 27, 2026 June 2, 2026
FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084) for Certain Patients with 1L Metastatic KRAS G12C-Mutant NSCLC June 2, 2026
Key Manufacturing and IND Preparation Milestones for ERNA-101 Toward First-in-Human Clinical Development Successfully Completed June 2, 2026
FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data June 2, 2026
CHMP Positive Opinion for Trodelvy in 1L Metastatic TNBC for Patients Not Candidates for PD-(L)1 Inhibitors June 2, 2026
FDA Orphan Drug Designation for EO2463 OncoMimics™ to treat indolent non-Hodgkin lymphoma June 2, 2026
FDA Orphan Drug Designation Granted to Oxaliplatin for the Treatment of Pancreatic Cancer June 2, 2026
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
