18/06/2026 US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL (Ref) The US FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for subcutaneous Lunsumio VELO (mosunetuzumab; CD20xCD3 T-cell engaging bispecific antibody) + Polivy (polatuzumab vedotin; CD79b targeting antibody-drug conjugate) in adults with relapsed/refractory

11/06/2026 FDA grants Priority Review for atezolizumab + chemo in stage III dMMR/MSI-H colon cancer Alembic wins tentative USFDA approval for Larotrectinib capsules FDA grants Priority Review for atezolizumab + chemo in stage III dMMR/MSI-H colon cancer (Ref) The FDA has accepted Roche’s supplemental Biologics License Application (sBLA) and granted priority review for Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chem

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

March 4th Week, 2026 Regulatory Events 🎯 The US FDA granted approval to Corcept Therapeutics Incorporated's relacorilant (selective glucocorticoid receptor antagonist) + nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. (Ref 1) ❓ What are the clinical outcomes that support this approval

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. Additionally,

24/02/2026 Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC Siren Biotechnology's SRN-101 received the FDA fast track designation for HGG Aktis Oncology's AKY-1189 received the FDA fast track designation for mUC Onconic Therapeutics' nesuparib received the FDA orphan drug designation for SCLC Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC (Ref) The US FDA granted traditional approval to Pfizer's encorafenib

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

17/02/2026 Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL J&J's RYBREVANT FASPRO™ received FDA approval for once a month dosing schedule for EGFRm NSCLC BMS' NDA for iberdomide + standard treatment has been accepted by the US FDA for R/R MM Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL (Ref) The US FDA has accepted for filing the NDA under the accelerated approval pathway for Deciph

13/02/2026 HanchorBio's HCB101 received the FDA orphan drug designation for gastric cancer HanchorBio's HCB101 received the FDA orphan drug designation for gastric cancer (Ref) The US FDA granted the Orphan Drug Designation to HanchorBio's HCB101 (CD47–SIRPα pathway inhibitor) for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes HCB101 is currently being e

11/02/2026 Biofrontera's sNDA for Ameluz® PDT in Superficial Basal Cell Carcinoma has been accepted by the US FDA Biofrontera's sNDA for Ameluz® PDT in Superficial Basal Cell Carcinoma has been accepted by the US FDA (Ref) The US FDA completed its filing review and accepted filing of Biofrontera's supplemental New Drug Application (sNDA) for Ameluz® (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED® red-light lamp series for the treatment o

28/01/2026 Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib as a 2L treatment for cholangiocarcinoma Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib as a 2L treatment for cholangiocarcinoma (Ref) Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib (FGFR2 inhibitor) as a second-line treatment option for cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement. Dong-Gun Kim, the company’s chief executive offi

21/01/2026 BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 Wugen's soficabtagene geleucel received the FDA Breakthrough Therapy Designation for T cell malignancies Opna Bio's zavabresib received the FDA orphan drug designation for myelofibrosis BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 (Ref) The US FDA granted the fast track designation to BioNTech's BNT11

09/07/2025 Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA (Ref) The US FDA granted the Breakthrough Device designation to Artera's ArteraAI Prostate (an AI precision medicine tool) intended to assist clinicians with risk-based decisions for patients with localized prostate cancer ArteraAI Prostate analyzes digital pathology images of the prostate cancer biopsy slide to prognosticate long-term outcomes, such as 10-yr risk of distant met

June 4th Week,2025 Regulatory Events 🎯 Daiichi Sankyo and AstraZeneca's Dato-DXd (Datroway; TROP2 ADC) has been granted an accelerated approval by the US FDA for the Tx of EGFR+ NSCLC patients previously treated with EGFR directed therapy and platinum-based chemotherapy. (Ref 1) ❓ Which other key regimens are expected to enter this setting in the near future? Special Designations ⭐ enGene's detalimogene voraplasmid (non-viral gene therapy) was granted a Regenerative Medici

24/06/2025 CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA (Ref) CARsgen Therapeutics submitted the New Drug Application (NDA) for satricabtagene autoleucel (satri-cel; an autologous anti-Claudin18.2 CAR-T) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior

June 3rd week, 2025 Regulatory Updates 🎯 Senti Biosciences received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or FLT3 targeting CAR-NK) for R/R AML (Ref 1) 👉 Why it matters: This is the first logic-gated CAR-NK with clinical data, demonstrating encouraging early results (ORR of 71.4% (n=7) with responses sustained beyond 8 months) 🎯 The US FDA granted ODD for CERo Therapeutics, Inc.’ CER-1236 (anti-TIM-4L CER-T), which is being evaluated in Ph1...

June 2nd week, 2025 ⭐ Deals & Collaborations 🤝Neowise Biotechnology granted BeOne Medicines rights to one of its proprietary antigen-specific TCR molecule under a non-exclusive licensing deal for the development of next-generation, iPSC-based off-the-shelf cell therapies for the Tx of Solid Tumors (Ref 1) ❓ What are the advantages of the off-the-shelf cell therapies? ⭐ Regulatory Updates 🎯 Myrio Tx received the US FDA approval for an IND application to initiate Ph1, N

May 5th & June 1st Week ⭐ Regulatory Updates 🎯 China’s NMPA granted Priority Review to CARsgen Therapeutics’ satri-cel (CT041; an autologous, anti-CLDN18.2 CAR-T) for ≥3L aGC/GEJA pts (Ref 1) ❓ What is the current landscape of cell therapies in GC? 🎯 Autolus Therapeutics’ obe-cel (an autologous, anti-CD-19 CAR-T) received a positive CHMP opinion in the EU for the treatment of R/R B-ALL in adults, based upon Ph1/2 FELIX/NCT04404660 study results (Ref 2) ❓ What are the ap

May 3rd Week, 2025 ⭐ Regulatory Update 🎯 The US FDA granted the RMAT designation to BrainChild Bio’s BCB-276 (an autologous, B7-H3 CAR-T) for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG) based on the positive survival data from the Ph1 BrainChild-03/NCT04185038 trial (Ref 1) ❓ Which other CAR-Ts are currently being investigated in clinical trials for DIPG? ⭐ Clinical DataReadouts 🔬 Updated data from the pivotal Ph2, iMMagine-1/NCT05396885 trial of Gilead Sci