Sept. 22, 2025 -- Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval

FDA grants Priority Review to idebenone for Leber Hereditary Optic Neuropathy (LHON), a disease for which there are no existing approved treatments in the U.S.; action date of February 28, 2026 People living with LHON suffer from rapid and severe loss of central vision due to mitochondrial dysfunction of retinal ganglion cells.1 Idebenone has the potential to be the first and only clinically proven short-chain benzoquinone, designed to target the underlying cause of LHON, mitochondrial dysfuncti

Sept. 19, 2025 -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia were updated to include revumenib as a category 2A recommendation for relapsed or refractory (R/R) acute myeloid leukemia (AML) with an NPM1 mutation (mNPM1).1 The update was based on positive pivota

ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results T cell responses included both mKRAS-specific CD4 and CD8 T cells in 85% of patients Sept. 17, 2025 -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or th

Sept. 17, 2025 -- The world’s first therapeutic drug to be equipped with NovalGen’s pioneering AutoRegulation (AR) technology has been approved for evaluation in the clinic by the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA). NVG-222, a next-generation, AutoRegulating T cell engager has been developed to increase the safety and durability of immunotherapies; and following confirmation of Clinical Trial Authorisation (CTA) by the MHRA, it is set to begin clinical evaluation l

Extension of the Phase 1b study will allow participants to continue dosing with GT-02287 for an additional nine months after completing the first 90-day dosing schedule The Phase 1b study enrolled 21 subjects and the last participants will complete 90 days of dosing in December 2025 Early results from the Phase 1b study to be presented at the International Congress of Parkinson’s Disease (PD) and Movement Disorders in October Sept. 18, 2025 -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or

Sept. 17, 2025 -- It is estimated that more than 13 million Americans struggle with post-traumatic stress disorder (PTSD). A new study, Hyperbaric Oxygen Therapy for PTSD: Threshold Effect for Sustained Symptom Improvement in a Biologically Based Treatment, shows hyperbaric oxygen therapy (HBOT) promotes neuroplasticity and alleviates symptoms in individuals with PTSD. The study was carried out through a joint collaboration between the Sagol Center for Hyperbaric Medicine and Research at Sham

Sept. 17, 2025 -- Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to RGT-61159 for the treatment of adenoid cystic carcinoma (ACC). RGT-61159 is a potent and selective orally available small molecule inhibitor of MYB through RNA splicing m

Sept. 17, 2025 -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on developing innovative long-acting depot injectable treatments, today provided an update on the clinical development program for its cariprazine once monthly injection. The company has enrolled the first patient into a Phase I/II study evaluating the product. Mapi Pharma’s injectable version of cariprazine, developed using its patented Depot technology, has demonstrated a

Dose optimization data from the Phase 1/2 study to be presented next month at ESMO 2025 Second Fast Track designation granted by FDA for CRB-701 Sept. 16, 2025 -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage oncology and obesity company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) prev