19/10/2026 US FDA approved Jemperli for MSI-H/dMMR locally advanced Rectal Cancer Quanta Therapeutics receives US FDA Fast Track Designation for QTX3034 in KRAS G12D-mutated CRC US FDA accepts UroGen's UGN-103 NDA for recurrent LG-IR-NMIBC, with PDUFA date on June 14, 2027 US FDA approved Jemperli for MSI-H/dMMR locally advanced Rectal Cancer (Ref) GSK announced US FDA approval of Jemperli (dostarlimab; anti-PD-1) as the first and only immunotherapy for adults with MSI-H/dMMR

14/10/2026 ImmunityBio secures US FDA expansion for ANKTIVA in BCG-Unresponsive Papillary Bladder Cancer Tab-cel BLA resubmission accepted by US FDA for EBV+ PTLD; PDUFA date set for March 2027 ImmunityBio secures US FDA expansion for ANKTIVA in BCG-Unresponsive Papillary Bladder Cancer (Ref) The US FDA expanded the approval of ANKTIVA® (nogapendekin alfa inbakicept-pmln; IL-15 receptor agonist) in combination with BCG to include patients with BCG-unresponsive non-muscle-inva

13/10/2026 US FDA accepts FYB206 for review as proposed Keytruda Biosimilar US FDA accepts FYB206 for review as proposed Keytruda Biosimilar (Ref) FYB206, a proposed biosimilar to Keytruda® (pembrolizumab), has been accepted for review by the US FDA, representing the first publicly announced FDA acceptance of a Keytruda biosimilar application The application was submitted by Formycon, with Zydus holding exclusive commercialization rights in the US and Canada US FDA accepted t

12/10/2026 Opamtistomig (PD-L1 x 4-1BB BsAb) receives US FDA Fast Track Designation in First-Line Biliary Tract Cancer In Phase 3 ACTION-1 trial, RYZ101 met primary endpoint of PFS in patients with GEP-NETs HLB/Elevar Resubmits US FDA application for first-line Liver Cancer combination US FDA grants Fast Track Designation to AST-301 for HER2-Positive Gastric Cancer Opamtistomig (PD-L1 x 4-1BB BsAb) receives US FDA Fast Track Designation in First-Line Biliary Tract Cancer (Ref

08/10/2026 US FDA approved atezolizumab + chemotherapy for adjuvant treatment of stage III dMMR Colon Cancer Perspective therapeutics receives US FDA Fast Track Designation for [212Pb]PSV359 in Solitary Fibrous Tumors US FDA granted Fast Track Designation to VIR-5500 in mCRPC China NMPA approves Enhertu as adjuvant therapy for HER2-positive early breast cancer and Datroway for metastatic TNBC US FDA approved atezolizumab + chemotherapy for adjuvant treatment of stage III dMMR

29/09/2026 Plinabulin secures US FDA Fast Track Designation as BeyondSpring advances Phase 3 DUBLIN-4 NSCLC program with strategic China funding agreement HUTCHMED announces US NDA Submission for ORPATHYS + TAGRISSO in MET-Driven EGFR-Mutated NSCLC US FDA grants Orphan Drug and Rare Pediatric Disease designations to UTR Therapeutics' MYCN-targeting candidate UTRxMYCN M1-14 Plinabulin secures US FDA Fast Track Designation as BeyondSpring advances Phase 3 DUBLIN-4 NSCLC program

20/08/2026 US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma US FDA Grants Fast Track Designation to Safusidenib for IDH1‑Mutant Glioma (Ref) Nuvation Bio announced that the US FDA has granted Fast Track Designation to safusidenib (IDH1 inhibitor) for the treatment of IDH1‑mutant glioma. This designation enables expedited regulatory review and closer FDA engagement Phase 2 J201 trial showed a confirmed objective response rate of 51.9%, with durable re

18/08/2026 BH-30643 earns US FDA Fast Track designation for pretreated NSCLC FDA Endorses Registrational Path for Pelareorep in RAS‑Mutant MSS Colorectal Cancer PLN-101095 Secures US FDA Fast Track for ICI-Refractory Solid Tumors US FDA Grants Fast Track to ETX‑19477, a Novel PARG Inhibitor for BRCA‑Mutated Breast Cancer BH-30643 earns US FDA Fast Track designation for pretreated NSCLC (Ref) BlossomHill Therapeutics announced that its investigational drug BH-30643, a macrocyc

22/07/2026 Ivonescimab plus chemotherapy delivers consistent overall survival gains across Western and Asian NSCLC patients, reinforcing FDA‑filed Phase III HARMONi data US FDA grants Priority Review for talazoparib + enzalutamide in HRR‑mutated mCSPC, with a decision expected in Q4 2026 US FDA Accepts NDA for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer GSK's Jideytro (zidesamtinib) Gets US FDA Approval for ROS1-Positive Lung Cancer Ivonescimab plus chemot

20/07/2026 US FDA Fast Track Designation Secured for Pelareorep in Advanced Anal Cancer US FDA Grants Tentative Approval for NATCO’s Generic Olaparib US FDA Fast Track Designation Secured for Pelareorep in Advanced Anal Cancer (Ref) Oncolytics Biotech's Pelareorep (double-stranded RNA immunotherapy), in combination with a checkpoint inhibitor, received Fast Track designation for second-line and later squamous cell carcinoma of the anal canal (SCAC) patients who progressed aft

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