The approval marks the first new treatment option for people living with progressive pulmonary fibrosis (PPF) in more than five years. PPF is a rare lung condition, more life-threatening than many forms of cancer, causing a continuous decline in lung function.1,2,3 PPF is the second approved indication in China for nerandomilast, following recent approvals in the U.S. and China for the treatment of idiopathic pulmonary fibrosis (IPF).4,5 China’s National Medical Products Administration (NMPA) h

Dec. 10, 2025 -- Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AJ1-11095 for the treatment of myelofibrosis, a debilitating blood cancer that affects approximately 20,000 patients in the U.S. AJ1-11095 is the first JAK2 inhibitor to enter the clinic that binds the Type II conformation of th

RMAT designation indicates that SENTI-202 has the potential to address unmet medical needs for patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) based on preliminary clinical evidence, and offers benefits of FDA working closely with Senti Bio to provide guidance and advice on generating the data needed to support approval of the product in an efficient manner Second FDA designation for SENTI-202 this year, after Orphan Drug Designation, is supported by clinical data showing de

ERJ Open Research article reports first clinical trial of glasmacinal (EP395) in COPD patients Glasmacinal, a novel macrolide, was well tolerated and reduced neutrophilic inflammation in COPD patients. Glasmacinal had no detectable impact on the lung microbiome supporting the in vitro findings of negligible anti-microbial activity. 8 December 2025 – EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’) is developing glasmacinal, an orally available macrolide with reduced antimicrobial resistance

Dec. 09, 2025 -- ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced the publication of data from its Phase 1b study of xelafaslatide (formerly ONL1204 Ophthalmic Solution) in Ophthalmology Science, the peer-reviewed journal of the American Academy of Ophthalmology. Xelafaslatide is an investigational, first-in-class small molecule Fas inhibitor designed to protect key retinal

Placebo-adjusted mean weight loss of 11.3% (27.3 lbs) with 120 mg dose in the 36-week Phase 2b ACCESS study with a 10.4% adverse event-related treatment discontinuation Placebo-adjusted mean weight loss up to 15.3% (35.5 lbs) observed with 240 mg dose in the exploratory ACCESS II study at 36 weeks No adverse event-related treatment discontinuations observed when starting at lower 2.5 mg dose in ACCESS Open Label Extension and Body Composition Study Data comprehensively support and inform advance

- NON-MTS & BILATERAL MTLE: First data reported from non-MTS and bilateral MTLE subjects demonstrate robust seizure reduction - LOW DOSE COHORT: 89% median reduction in disabling seizures for unilateral subjects with MTS at the primary efficacy evaluation period of 7-12 months post administration (n=9) - HIGH DOSE COHORT: 78% median reduction in disabling seizures for unilateral subjects with MTS at interim efficacy evaluation period of 4-6 months post administration (n=9) - DURABILITY: Several

Dr. Reddy’s receives exclusive rights to develop and commercialise Eftilagimod Alfa in all countries outside North America, Europe, Japan, and Greater China Under the terms, Immutep to receive upfront payment of USD 20 million (~AUD 30.2 million) and is also eligible to receive potential regulatory development and commercial milestone payments of up to USD 349.5 million (~AUD 528.4 million), plus double-digit royalties on commercial sales Dec. 08, 2025 -- Immutep Limited (ASX: IMM; NASDAQ: IMM

Ragistomig is a 4-1BB X PD-L1 bispecific antibody, designed to treat patients who are relapsed or refractory to checkpoint inhibitors, a multi-billion dollar drug class hampered by widespread resistance The Phase 1 ragistomig study achieved its objective, as the new Q6W extended dosing interval produced strong anti-tumor efficacy in PD-L1-non-responders, with an improved safety profile The interim results, including immunological data on CD8+ cell proliferation and memory T-cell activation, are

December 7, 2025 Trial demonstrated treatment with fixed duration EPKINLY plus rituximab and lenalidomide (EPKINLY+ R2) resulted in statistically significant and clinically meaningful reduction in the risk of disease progression or death and overall response compared to R2 alone EPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific-based therapy for follicular lymphoma in the second-line setting Results of EPCORE FL-1 simultaneously publishe