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

05/08/2025 Immutep received positive feedback from the FDA for the late-stage development of Eftilagimod Alfa in SCCHN (Ref) Immutep received positive and constructive feedback from the US FDA regarding future clinical development of eftilagimod alpha (soluble LAG-3 protein) as a first-line Tx of R/M SCCHN with PD-L1 CPS <1. Based on available data from cohort B of the Ph2b TACTI-003 trial of efti + pembro in R/M SCCHN with CPS <1, the FDA agreed on the potential of the comb

04/08/2025 Alphamab's IND application for JSKN022 was accepted by China's CDE (Ref) Alphamab Oncology's IND application for JSKN022 (PD-L1 x integrin αvβ6 bispecific antibody-drug conjugate) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company plans to initiate a first-in-human trial of JSKN022 for the treatment of advanced malignant solid tumors The Ph1 trial will evaluate the safety, tolerability, PK/P

11/07/2025 Cel-Sci to partner with a leading Saudi Arabian pharma company for Multikine in the Tx of Head & Neck Cancer (Ref) Cel-Sci Corporation announced an agreement with one of Saudi Arabia’s premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine (Leukocyte Interleukin, Injection) in the Kingdom of Saudia Arabia The Saudi pharmaceutical partner which will file a Breakthrough Medicine Designation appl

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies (Ref) MAIA Biotechnology entered into a clinical master supply agreement with Roche for future trials evaluating MAIA’s ateganosine (THIO; telomere-targeting agent) in combination with Roche's atezolizumab (Tecentriq; anti-PD-L1) for the treatment of multiple hard-to-treat cancers. Ateganosine's highly synergistic and effective activity in combination with at