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 Pharmaceuticals' Libtayo® (cemiplimab; PD-1 inhibitor) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The approval is based on results from the pivotal Phase 3 C-POST trial of adjuvant Libtayo vs placebo in patients with CSCC at high risk of recurrenc

07/10/2025 Precision NeuroMed's cinetredekin besudotox received the FDA orphan drug designation for GBM (Ref) The US FDA granted the orphan drug designation to Precision NeuroMed's cinetredekin besudotox (IL13PE38 ; cytotoxic protein) for the treatment of glioblastoma (GBM). The advanced convection-enhanced delivery (CED) platform delivers therapeutic concentrations of cinetredekin besudotox to tumor-infiltrated regions of the brain Sandeep Kunwar, CEO and Co-Founder, Precisi

October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Jazz Pharmaceuticals' lurbinectedin (DNA alkylating agent) + Roche's atezolizumab (anti-PD-L1) as a maintenance Tx for adults with ES-SCLC whose disease has not progressed after first-line induction Tx with atezolizumab, carboplatin and etoposide. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (HER2 ADC) followed by paclitaxel

September 4th Week, 2025 Regulatory Events 🎯 The US FDA approved Eli Lilly and Company's imlunestrant (oral estrogen receptor antagonist) for the Tx of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 Nuvalent, Inc., completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine

02/10/2025 Aminex Therapeutics' AMXT 1501 + DFMO received the FDA Orphan Drug Designation for Neuroblastoma (Ref) The US FDA granted the Orphan Drug Designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of patients with neuroblastoma. Mark Burns, CSO and President, Aminex Therapeutics: "Receiving Orphan Drug Designation for AMXT 1501 in combination with DFMO represents an important milestone in our mission to

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

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

25/09/2025 Eli Lilly and Company's Inluriyo has been approved in the US for ER+, HER2–, ESR1-mutated breast cancer (Ref) The US FDA approved Eli Lilly and Company's Inluriyo (imlunestrant, oral estrogen receptor antagonist) for the treatment of adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The FDA approval is based on the results of the Phase 3 EMBER-3 trial Inluriyo reduced the

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

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous administration (Ref) The EMA's CHMP adopted a positive opinion recommending the approval of Merck & Co./MSD's pembro (anti-PD-1) mono as a neoadjuvant Tx followed by adjuvant pembro + RT ± cisplatin after surgery, then pembro mono for resectable locally advanced SCCHN with PD-L1 CPS ≥1. The recommendation is based on results from the Ph3 KEYNOTE

12/09/2025 The NDA for Alphamab Oncology and CSPC Pharma's anbenitamab + chemo has been accepted by the NMPA for HER2 +ve GC/GEJC (Ref) China's National Medical Products Administration accepted the NDA for Alphamab Oncology and CSPC Pharma's anbenitamab injection (KN026; anti-HER2 BsAb) in combination with chemotherapy for the treatment of HER2 +ve, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior system

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

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer (Ref) The US FDA granted the Fast Track Designation to Greenwich LifeSciences' GLSI-100 (GP2 + GM-CSF) for the treatment of patients with HLA-A*02 genotype and HER2+ve breast cancer who have completed treatment with standard of care HER2/neu targeted therapy. Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, Greenwich: "Greenwich is pleased that the FDA sees the

09/09/2025 Johnson & Johnson's INLEXZO received US FDA approval for NMIBC (Ref) The US FDA approved Johnson & Johnson's INLEXZO™ (TAR-200; gemcitabine intravesical system) for the treatment of adult patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The approval is based on results from the Phase 2b SunRISe-1/NCT04640623 trial Jennifer Taubert, Executive Vice President, Worldwide Chairman,

08/09/2025 Beyond Air's BA-101 received the Orphan Drug Designation for GBM (Ref) The US FDA granted the Orphan Drug Designation to Beyond Air's BA-101 for the treatment of Glioblastoma (GBM). Amir Avniel, CEO, NeuroNOS: “We are pleased to receive orphan drug designation from the FDA for the treatment of glioblastoma. This is our second orphan drug designation and further highlights our mission to bring targeted therapies to individuals and families affected by rare neurologi

05/09/2025 CERo Therapeutics' CER-1236 received the FDA Fast Track Designation for AML (Ref) The US FDA granted the Fast Track Designation to CERo Therapeutics' CER-1236 (TIM-4 ligand targeting CER-T therapy) for the treatment of Acute Myeloid Leukemia (AML). Chris Ehrlich, CEO, CERo Therapeutics: “These FDA designations are important additional validation with regard to the urgency of the condition as well as the potential that the agency sees in the existing data as submitt

04/09/2025 Eli Lilly and Company's olomorasib in combination with Keytruda received the FDA Breakthrough Therapy designation for metastatic KRAS G12C-mutant NSCLC (Ref) The US FDA granted the Breakthrough Therapy designation to Eli Lilly and Company's olomorasib (KRAS G12C inhibitor) + Merck & Co/MSD's pembrolizumab (anti-PD-1), for the first-line treatment of unresectable advanced or metastatic NSCLC with a KRAS G12C mutation and PD-L1 expression ≥ 50%. The designation was b

03/09/2025 Boehringer Ingelheim's zongertinib received the FDA Breakthrough Therapy Designation for first-line HER2-mutant advanced NSCLC (Ref) The US FDA granted the Breakthrough Therapy Designation to Boehringer Ingelheim's zongertinib (HERNEXEOS; HER2-selective tyrosine kinase inhibitor) for the first-line treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 tyrosine kinase domain activating mutations. Vicky Brown, Senior Vi

01/09/2025 Boehringer’s zongertinib received accelerated approval in China for HER2-mutant advanced NSCLC ( Ref ) China’s National...

28/08/2025 TOLREMO Therapeutics' TT125-802 received two fast track designations from the US FDA for NSCLC (Ref) The US FDA granted two fast track designations to TOLREMO Therapeutics' TT125-802 (CBP/p300 inhibitor) for the treatment of NSCLC: For the treatment of patients with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R substitution mutation, with disease progression on at least one line of prior therapy including an EGFR inhibitor For