Jan. 23, 2026 -- Alveus Therapeutics, Inc. (“Alveus”), a clinical-stage biotechnology company developing next-generation therapies for obesity and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ALV-100, the company’s lead investigational therapy for chronic weight management, enabling initiation of a Phase 1b clinical study. The first patient was dosed last week. ALV-100 is a bifunctional gluco

-Topline data from the Phase II study for the treatment of diabetes are expected in the third quarter of 2026. -ASC30 demonstrated placebo-adjusted weight loss of up to 7.7% in a recently completed 13-week U.S. Phase II study in participants with obesity or overweight, with better gastrointestinal tolerability. No hepatic safety signal was observed. Jan. 25, 2026 -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the first participants have been dosed in a U.S. 13-week Phase

Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has completed the regulatory submission for XEOMIN® (incobotulinumtoxinA) for the treatment of spasticity of the lower and upper limb in children and adolescents aged 2–17 years in the European Union (EU) and European Economic Area (EEA). If approved, the indication would expand access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe

Jan. 22, 2026 -- CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced initiation of the BENEFIT-HF clinical trial, a landmark randomized study supported by CMS Category B IDE coverage and designed to evaluate the impact of Barostim™ in a significantly expanded heart failure population. Barostim™ is an implantable device that delivers electrical

Sanofi's amlitelimab confirms its potential in atopic dermatitis In the SHORE phase 3 study, amlitelimab in combination with topical therapies met all primary and key secondary endpoints at Week 24 with efficacy progressively increasing throughout the treatment period with some patients improving as early as Week 2 In the COAST 2 phase 3 study, amlitelimab demonstrated statistically significant efficacy on vIGA-AD 0/1, the primary endpoint as assessed for the US and US reference countries, and

Statistically-significant reduction in the relative change from baseline in 24-hour objective cough frequency observed across all dose groups of nalbuphine ER at Week 6 with statistically-significant cough reduction as early as Week 2, the first time point measured Over 60% of nalbuphine ER-treated patients achieved at least a 50% reduction in 24-hour cough frequency at Week 6 vs baseline Patient-reported outcome measure of cough frequency was consistent with reduction observed with objective

Jan. 22, 2026 -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that updated interim data from the cohort of BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) patients in the ongoing Phase 2 ADVANCED-2 trial of TARA-002 will be featured at the upcoming American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place from February 26, 20

Rznomics, a biopharmaceutical company specializing in RNA-based gene therapies (CEO Seong-wook Lee), announced today that its lead anti-cancer candidate, RZ-001, has been selected as a clinical-stage project for the “2025 1st National New Drug Development Project” by the Korea Drug Development Fund (KDDF). The National New Drug Development Project is a pan-governmental R&D initiative aimed at strengthening the global competitiveness of the Korean pharmaceutical and biotech industries. Following

The Austin, TX-based biotech told Endpoints News it plans to submit an application to the FDA in April that would seek approval for its drug, Aqneursa. Known generically as N-acetyl-L-leucine, Aqneursa was first approved in 2024 to treat neurological symptoms related to another rare disease called Niemann-Pick disease type C. There are currently no approved treatments specifically for ataxia-telangiectasia. Seventy-three patients with the disorder were enrolled as part of the Phase 3 trial, an

Novartis has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ianalumab, a treatment for Sjögren’s disease, the second most prevalent rheumatic autoimmune condition. Ianalumab is a fully human monoclonal antibody that targets B-cells and inhibits their activation and survival by blocking B-cell activating factor receptor (BAFF-R). Novartis intends to submit ianalumab for regulatory approval globally in early 2026. If approved, it would re