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

01/04/2026 Cogent completed the NDA submission for bezuclastinib in GIST A2 Bio's A2B543 CAR-T received the FDA fast track designation for certain solid tumors FORE Biotherapeutics' plixorafenib received the FDA breakthrough therapy designation for certain gliomas Cogent completed the NDA submission for bezuclastinib in GIST ( Ref ) Cogent Biosciences completed the NDA submission to the US FDA for bezuclastinib (KIT inhibitor) in patients with Gastrointestinal Stromal Tumors

23/03/2026 AstraZeneca & Daiichi Sankyo's ENHERTU received approval in Japan for HER2+ solid cancers AstraZeneca & Daiichi Sankyo's ENHERTU received approval in Japan for HER2+ solid cancers ( Ref ) Japan’s Ministry of Health, Labour and Welfare (MHLW) granted approval to AstraZeneca & Daiichi Sankyo's ENHERTU® (trastuzumab deruxtecan) for the treatment of adult patients with HER2+, advanced or recurrent solid cancers refractory or intolerant to standard treatments. The appro

21/03/2026 Dizal's Phase 3 WU-KONG28 trial of ZEGFROVY met its PFS endpoint as a first-line treatment of EGFRexon20ins NSCLC Dizal's Phase 3 WU-KONG28 trial of ZEGFROVY met its PFS endpoint as a first-line treatment of EGFRexon20ins NSCLC ( Ref ) The multinational Phase 3 WU-KONG28 trial evaluating Dizal's ZEGFROVY® (sunvozertinib) monotherapy as first-line treatment in NSCLC with EGFR exon20ins met its primary endpoint of PFS. The WU-KONG28 study evaluated ZEGFROVY versus pl

20/03/2026 BMS received approvals from US FDA and EC for Opdivo-based treatment combinations for classical Hodgkin Lymphoma BMS received approvals from US FDA and EC for Opdivo-based treatment combinations for classical Hodgkin Lymphoma ( Ref ) The US FDA approved Bristol Myers Squibb's nivolumab (anti-PD-1) + doxorubicin + vinblastine + dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL. Additionall

16/03/2026 AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers Telix resubmitted NDA to the US FDA for TLX101-Px brain cancer imaging candidate AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers ( Ref ) The EC granted approval to AstraZeneca’s durvalumab (anti-PD-L1) + standard-of-care FLOT chemotherapy for the treatment of adult patients with resecta

20/02/2026 The combination of venetoclax and acalabrutinib has been approved by the US FDA for CLL The combination of venetoclax and acalabrutinib has been approved by the US FDA for CLL ( Ref ) The US FDA has approved a sNDA for Abbvie & Genentech's venetoclax (BCL-2 inhibitor) + AstraZeneca's acalabrutinib (BTK inhibitor) for the treatment of previously untreated adult patients with CLL The approval is supported by data from the Phase 3 AMPLIFY trial Dr. Brian Koffman, co-f

05/02/2026 Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma ( Ref ) The US FDA granted the orphan drug designation to Partner Therapeutics' zenocutuzumab‑zbco (HER2xHER3 bispecific antibody) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma. Zenocutuzumab is being developed in a subset of

26/01/2026 Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST Innovent Biologics' IBI3003 received the FDA Fast Track Designation for multiple myeloma Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST ( Ref ) The US FDA granted the Breakthrough Therapy Designation to Cogent Biosciences' bezuclastinib (tyrosine kinase inhibitor) in combination with sunitinib for patien

29/12/2025 HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma Genmab discontinued the clinical development of acasunlimab following a portfolio review HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma ( Ref ) China's NMPA accepted and granted priority review status to HUTCHMED Limited's NDA for fanregratinib (FGFR 1/2/3 inhibitor) for the treatment of

23/12/2025 Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC SN Bioscience's SNB-101 received the FDA orphan drug designation for GC/GEJC Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC ( Ref ) The US FDA granted the orphan drug designation to Alphamab Oncology and 3D (Beijing) Medicines' envafolimab (KN035; subcutaneously injectable PD-L1 inhibitor) for

22/12/2025 Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan received the FDA breakthrough therapy designation for early breast cancer AstraZeneca's ceralasertib + durvalumab failed to meet the OS endpoint in PD(L)-1 failed NSCLC Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma ( Ref ) The US FDA granted accelerated approval to Roche's Lunsumio VE

20/12/2025 Alphamab & CSPC's JSKN003 ADC received the FDA Breakthrough Therapy Designation for the Treatment of PROC Alphamab & CSPC's JSKN003 ADC received the FDA Breakthrough Therapy Designation for the Treatment of PROC ( Ref ) The US FDA granted the breakthrough therapy designation to Alphamab Oncology and CSPC Pharma's JSKN003 (biparatopic HER2-targeting ADC) for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian

16/12/2025 Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases ( Ref ) The US FDA granted the fast track designation (FTD) to Adagene's muzastotug (ADG126; masked anti-CTLA-4) + pembrolizumab for the treatment of adult patients with microsatellite stable metastatic colorectal can

09/12/2025 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies Zydus and Formycon enter into an exclusive partnership for the Keytruda biosimilar, FYB206 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202 (logic gated off-the-shelf CAR-NK cell therapy) for the treatment of.

08/12/2025 Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer Chimeric Therapeutics' CHM CDH17 received the FDA orphan drug designation for Gastric Cancer ( Ref ) The US FDA granted the orphan drug designation to Chimeric Therapeutics' CHM CDH17 (CDH17-targeting CAR-T cell therapy) in the treatment of Gastric Cancer. Dr Rebecca McQualter, CEO, Chimeric Therapeutics: “ This is a great step forward in the development of CHM CDH17 to ser

21/11/2025 Pembrolizumab + enfortumab vedotin received the FDA approval for MIBC ( Ref ) The US FDA granted approval to Merck & Co./MSD pembrolizumab (anti-PD-1; both IV and SC formulations) in combination with Pfizer and Astellas' enfortumab vedotin (Nectin-4 ADC) as a neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemothera

19/11/2025 Roche's Lunsumio SC received conditional approval in EU for R/R FL ( Ref ) The European Commission granted conditional marketing authorisation to Roche's mosunetuzumab (Lunsumio; CD20 x CD3 bispecific antibody) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The approval is based on results from the Phase I/II GO29781 trial in which Lunsumio SC had pharmac

06/11/2025 Johnson & Johnson's Darzalex Faspro has been approved by the FDA for HR-SMM ( Ref ) The US FDA approved Johnson & Johnson's Darzalex Faspro® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). The approval is based on results from the Ph3 AQUILA/NCT03301220 trial, which evaluated the efficacy and safety of Darzalex Faspro vs active monitoring (or “Watch and Wait”) in patients with

08/10/2025 Regeneron's cemiplimab has been approved by the US FDA for the adjuvant Tx of CSCC ( Ref ) The US FDA approved Regeneron...