15/05/2026 FDA approved ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of neoadjuvant and adjuvant HER2+ early breast cancer UGN-103 delivers 94.5% six‑month durability in Phase 3 UTOPIA trial, with NDA submission planned for Q3 2026 to advance next‑generation RTGel therapy in recurrent LG‑IR‑NMIBC In Ph3 trial, Regeneron’s fianlimab + cemiplimab showed numeric PFS gain but missed statistical significance vs pembrolizumab in advanced or metastatic Melanoma CAN‑24

14/05/2026 Alembic secures USFDA tentative nod for Darolutamide tablets, 300 mg In Ph3 VOLGA trial, durvalumab + enfortumab vedotin significantly improved EFS and OS in MIBC Celcuity expands Phase 3 VIKTORIA-2 trial to include endocrine‑sensitive HR+/HER2‑ breast cancer patients Astellas files sNDA in Japan for PADCEV + Keytruda in cisplatin‑eligible muscle‑invasive bladder cancer, backed by Phase 3 EV‑304 survival benefit Alembic secures USFDA tentative nod for Darolutamide

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

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 approva

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 resectabl

09/03/2026 Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC BMS announced positive Ph3 data of oral mezigdomide regimen in R/R Multiple Myeloma AstraZeneca and Daiichi Sankyo’s Enhertu received priority review status for HER2-positive early breast cancer Roche announced failure of the Phase 3 persevERA Breast Cancer trial Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC (Ref)

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-fou

19/02/2026 Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer Pilatus Biosciences' PLT012 received the FDA Fast Track designation for HCC Genentech's NDA for giredestrant + everolimus has been accepted by the US FDA for certain patients with breast cancer Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer (Ref) The EMA has validated the type II variation marketing authoriz

10/02/2026 Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer AstraZeneca & Daiichi's Phase 3 TROPION-Lung12 trial in stage I NSCLC has been discontinued Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC (Ref) The US FDA granted the fast track designation to Abbisko Therapeut

03/02/2026 Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer The US FDA granted priority review status to Datroway for the treatment of TNBC Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer (Ref) The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults with

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 VELO

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies (Ref) The US FDA accepted Orca Bio's BLA seeking approval for Orca-T (allogeneic T-cell immunotherapy) as a treatment for hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes. Priority Review status has been granted with a PDUFA target action date of April 6, 2026 The BLA submission was based on positive resul

01/10/2025 The US FDA accepted the sBLA for Enhertu® followed by THP for HER2+ve early-stage Breast Cancer (Ref) Daiichi Sankyo and AstraZeneca’s sBLA for famtrastuzumab deruxtecan-nxki (ENHERTU; HER2 ADC) followed by paclitaxel, trastuzumab and pertuzumab (THP) has been accepted for review by the US FDA for the neoadjuvant treatment of adult patients with HER2 +ve stage 2/3 breast cancer. The acceptance is based on results from the Phase 3 DESTINY-Breast11 trial The PDUFA da

29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction (Ref) Genmab and Merus announced a transaction agreement pursuant to which Genmab will acquire all the shares of Merus for $97.00 per share in an all-cash transaction representing a transaction value of ~$8.0 billion. The transaction has been unanimously approved by the Boards of Directors of both companies A wholly owned subsidiary of Genmab will commence a tender offer for 100% of Merus’ common

24/09/2025 AstraZeneca and Daiichi's trastuzumab deruxtecan + pertuzumab received priority review status for first-line HER2+ve breast cancer (Ref) The US FDA accepted and granted Priority Review to AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (Enhertu; HER2 ADC) + pertuzumab for the first-line Tx of adult patients with unresectable or metastatic HER2-positive breast cancer. The PDUFA date is anticipated during Q1'26 The sBLA was based on results from th

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC (Ref) Nuvalent, Inc has completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine kinase inhibitor) in TKI pre-treated patients with advanced ROS1-positive NSCLC. SOPHiA GENETICS expanded its collaboration with AstraZeneca for an optimized NGS solution (Ref) SOPHiA GENETICS and AstraZeneca announced an expansion of their collaboration from the W

11/09/2025 Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan has been accepted for review in the EU for HER2 +ve solid tumors (Ref) The EMA validated the Type II Variation marketing authorization application for Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan (ENHERTU; HER2 ADC) for the treatment of adult patients with HER2 +ve, unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treatment options. The a

21/07/2025 Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC (Ref) The European Commission granted marketing authorization to Bayer and Orion Corporation’s darolutamide (Nubeqa; oral androgen receptor inhibitor) + androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer The approval was based on results from the pivotal Phase 3 ARANOTE trial in which darolutamide + ADT significantly reduced the risk of rad

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer (Ref) The US FDA granted Priority Review to Johnson & Johnson's NDA filed for TAR-200 (intravesical gemcitabine releasing system) for the treatment of BCG-unresponsive, high-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The filing was based on results from the Phase 2b SunRISe-1 trial which demonstrated a CR of 82.4% wi

04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer (Ref) AstraZeneca’s neoadjuvant durvalumab (Imfinzi; anti-PD-L1) in combination with gemcitabine and cisplatin followed by adjuvant durvalumab monotherapy after radical cystectomy for adult patients with resectable muscle-invasive bladder cancer (MIBC) has been approved in the EU The approval follows the positive CHMP opinion and is based on results from the Phas