– If approved, mirdametinib is expected to be the first and only therapy in the European Union with marketing authorization for both adults and children with NF1-PN – – Decision from European Commission expected in the third quarter of 2025 – May 23, 2025 -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human U

Purified Cortrophin Gel is the only ACTH therapy approved by the FDA for the treatment of acute gout flares Trial to be conducted by Dr. Hyon Choi at Massachusetts General Hospital and will compare the safety and efficacy of two dose levels of Purified Cortrophin Gel for the treatment of acute gout flares May 22, 2025 -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the initiation of a Phase 4 clinical trial at Massachusetts General Hospital to compare the safet

22 May 2025– LIfT BioSciences, (‘LIfT’ or ‘the Company’), a rapidly emerging biotech and the global leader in neutrophil immunotherapies, today announces that preclinical data showing the wider therapeutic potential of its first-in-class Immunomodulatory Alpha Neutrophils (IMANs) was presented at the American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting held from from 13 – 17 May in New Orleans, USA. The poster highlights how IMANs, while demonstrating strong anti-tumour activity,

May 21, 2025 -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the TNG456 Phase 1/2 trial in patients with MTAP-deleted solid tumors, with a focus on glioblastoma (GBM). TNG456 is a next-generation, brain-penetrant, MTA-cooperative PRMT5 inhibitor. “Dosing the first patient in the TNG456 Phase 1/2 trial marks a significant step fo

– Patient enrollment exceeding expectations – – 14 U.S. sites actively enrolling; 10 U.S. sites added since last update – – Anticipate completing NEXICART-2 clinical trial ahead of schedule – May 23, 2025 -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or "IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that 14 U.S. sites are actively enrolling in U.S. multi-site study NEXICART-2. This mil

Updated data from the pivotal phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant1 89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment1 Timely initiation of effective therapy at relapse or after initial therapy fai

Biodexa Announces Award of Additional $3.0M Grant from CPRIT to Support Registrational eRapa Phase 3 Program in FAP Brings Total CPRIT Grant Funding for eRapa Phase 3 Program to $20.0M Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced its collaboration partner, Rapamycin Holdings, Inc. d/b/a Emtora Biosciences (“Em

Istaroxime has previously completed two positive Phase 2 studies in SCAI Stage B cardiogenic shock; the SEISMiC C study in SCAI Stage C cardiogenic shock is another step progressing to the istaroxime cardiogenic shock Phase 3 program May 22, 2025 -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue-generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, today

Positive recommendation based on phase III INAVO120 data showing ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant more than doubled progression-free survival in the first-line setting1 The Itovebi-based regimen also demonstrated a statistically significant and clinically meaningful benefit in overall survival (OS) in the final OS analysis Final OS data will be presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting 23 May 2025 - Roche

• Significantly expands IB-Stim’s total addressable market • Clearance covers patients aged 8–21 • Seamless go-to-market strategy with existing reimbursement and provider infrastructure May 20, 2025 -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced that it has received FDA 510(k) clearance for IB-Stim™ for the