OCTOBER 6, 2025 — 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 and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair®

Oct. 03, 2025 -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics using its proprietary CAB platform for the treatment of solid tumors, today announced that clinical data for its investigational AXL-targeting antibody-drug conjugate (ADC), mecbotamab vedotin (BA3011), will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting to be held at Nati

DT-101 is designed to allow effective modulation of the AMPA receptor without compromising safety Phase 2 clinical trial initiation anticipated before the end of 2025 Trial builds on positive Phase 1 study that showed DT-101 was well tolerated and demonstrated target engagement 2 October 2025 – Draig Therapeutics (“Draig”), a clinical-stage company aiming to transform the treatment of neuropsychiatric diseases, today announces that it will initiate a Phase 2 study of DT-101, a next-generation A

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study1 First and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLC2 Regimen recommended in National Comprehensive Cancer Network® Guidelines for SCLC*3 3 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approv

Health Canada approved AGAMREE for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only approved therapy for DMD in Canada October 3, 2025 – Santhera Pharmaceuticals (SIX: SANN) today notes that Health Canada has approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older following Priority Review, marking the first approved treatment for the disease in Canada.

Oct. 02, 2025 -- Nacuity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other diseases caused by oxidative stress, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s proprietary, investigational therapy for the treatment of patients with retinitis pigmentosa (RP). “Breakthrough Therapy Designatio

Oct. 01, 2025 -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-ow

AAVB-039 addresses the root cause of the disease, benefitting patients with any ABCA4 mutation AAVB-039 is currently being assessed in the CELESTE interventional clinical trial and we continue recruiting in our STELLA observational study Oct. 02, 2025 --- AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company developing gene therapies for inherited retinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted AAVB-039, the company’s investigation

ANAVEX3-71-002 trial achieved its primary endpoint demonstrating safety and tolerability in both male and female adults Oral ANAVEX®3-71 tablet exhibits superior pharmacokinetics compared to the current immediate-release oral capsule, enabling once-daily dosing NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkins

CRYPTICS study met the primary efficacy endpoint measure, 24-hour chest tube drainage (Difference in LS Means was 142.0 mL; 95.576% confidence interval of volume difference lower than noninferiority margin) Sensitivity analyses of the primary endpoint were consistent and supportive Comprehensive review of the study efficacy data based on clinically relevant secondary endpoints further supports noninferiority of CLPH-511 to room temperature platelets Adverse events were well balanced between the