20/04/2026 Arcus halts Lung Cancer Trial With Gilead After Futility Analysis FDA granted Fast Track designation for Lunresertib + Zedoresertib in Platinum-Resistant Ovarian Cancer FDA Grants Orphan Drug Status to Orion’s ODM-212 for Mesothelioma FDA Grants Priority Review for PADCEV + Keytruda in Muscle-Invasive Bladder Cancer Arcus halts Lung Cancer Trial With Gilead After Futility Analysis (Ref) Arcus Biosciences has halted its Phase 3 lung cancer trial with Gilead Sciences

12/03/2026 Aminex Therapeutics' AMXT 1501 received the FDA ODD for Glioma Aminex Therapeutics' AMXT 1501 received the FDA ODD for Glioma (Ref) The US FDA granted the orphan drug designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG). The Beat Childhood Cancer Research Consortium at Penn State College of Medicine, in partnership with Aminex,

02/02/2026 OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma (Ref) OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2-bioengineered form of Listeria monocytogenes) in the p

20/01/2026 In the Ph2b KN-942 trial, Moderna and Merck's intismeran autogene + pembro showed sustained RFS benefit at 5 years of median follow-up Lilly's sofetabart mipitecan received the FDA Breakthrough Therapy designation for platinum-resistant ovarian cancer Celcuity's NDA for gedatolisib has been accepted for priority review for advanced breast cancer Lantern Pharma's LP-284 received the FDA orphan drug designation for soft tissue sarcomas In the Ph2b KN-942 trial, Moder

14/01/2026 Nanjing Leads Biolabs' opamtistomig received the FDA fast track designation for extra-pulmonary neuroendocrine carcinoma Nanjing Leads Biolabs' opamtistomig received the FDA fast track designation for extra-pulmonary neuroendocrine carcinoma (Ref) The US FDA granted fast track designation to Nanjing Leads Biolabs' opamtistomig (LBL-024; PD-L1 x 4-1BB bispecific antibody) for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC). Dr. Charles Cai, CMO,

10/12/2025 GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC Ajax Therapeutics' AJ1-11095 received the FDA orphan drug designation for myelofibrosis GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC (Ref) The US FDA granted the orphan drug designation to GSK's risvutatug rezetecan (B7-H3-targeted ADC) for the treatment of small-cell lung cancer (SCLC). The ODD was based on preliminary clinical data of the Phase 1 ARTEMIS-0

23/11/2025 NovelWise's NBM-BMX received the FDA orphan drug designation for uveal melanoma (Ref) The US FDA granted the orphan drug designation to NovelWise Pharmaceutical Corporation's NBM-BMX (selective HDAC8 inhibitor) for the treatment of uveal melanoma. John Soong, MD, Chief Executive Officer, NovelWise: “Receiving both Fast Track Designation and now Orphan Drug Designation underscores NBM-BMX’s promise in addressing a high unmet medical need for patients with uveal mela

30/09/2025 Umoja Biopharma's UB-VV111 in vivo CAR T cell therapy received the FDA fast track designation for B-Cell Malignancies (Ref) The US FDA granted the fast track designation to Umoja Biopharma's UB-VV111 (off-the-shelf drug product that generates CD19-directed CAR T cells in vivo) for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of

20/08/2025 Invion's INV043 received the FDA's Orphan Drug Designation for anal cancer (Ref) The US FDA granted the Orphan Drug Designation to Invion's INV043 (photodynamic therapy) for the treatment of anal cancer. Invion is working with Peter Mac to conduct an trial of INV043 in combination with ICIs in anogenital cancer including anal, vulvar and penile cancers Prof Thian Chew, Executive Chairman and CEO, Invion: “This regulatory milestone enhances our ability to bring INV0

06/08/2025 Jazz Pharmaceuticals' Modeyso received accelerated approval from the FDA for Recurrent H3 K27M-mutant Diffuse Midline Glioma (Ref) The US FDA granted accelerated approval to Jazz Pharmaceuticals' Modeyso™ (dordaviprone; oral antagonist of dopamine receptor D2 and agonist of ClpP) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Contin

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC (Ref) The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + gemcitabine + cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy The approval is based on results from the Phase 3 RATIONALE-309 trial which met the primary endpoint of PFS (HR 0.52; p<0.0001)