Dec. 30, 2025 -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM). The submission is based on positive clinical data from the SUMMIT pivotal trial and follows the Breakthrough Therapy Designation for bezuclastinib in patients wit

— NDA supported by positive Phase II registration study data in Chinese patients; follows Breakthrough Therapy Designation granted in 2023 — — Savolitinib has the potential to become the first selective MET inhibitor in China for MET-amplified gastric cancer — Dec. 30, 2025 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophage

Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma Approval based on global phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function compared to placebo (by 4.68% to 5.32%) Dupixent is the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized phase 3 study, and inhibits IL-4 and IL-13, two key and central driver

Dec. 23, 2025 -- LAPIX Therapeutics, Inc. (“LAPIX”), a clinical-stage biopharmaceutical company developing first-in-class, orally delivered immune-tolerance-restoring therapies, announced today that the first patient has been dosed in its Phase Ib clinical study of LPX-TI641 in adults with atopic dermatitis (AD). The Phase Ib study evaluates LPX-TI641 in a chronic inflammatory disease characterized by Th2-mediated immune dysregulation, extending the company’s prior clinical work in autoimmune

Dec. 23, 2025 -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a phase II clinical trial of its novel TYK2 inhibitor ICP-488 for the treatment of cutaneous lupus erythematosus (CLE). ICP-488 is an oral, potent, and selective

Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia Novel treatment targets BTK through multi-immune modulation to help address the underlying causes of ITP Approval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptoms ITP is a rare disease of complex immune dysregulation leading to lower platelet counts, bleeding, and reduced quality of life December 23, 2025 – The European Com

Dec. 23, 2025 -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel payloads, today announced the initiation of GMP manufacturing activities to support the development of AKTX-101, the Company’s lead ADC program. Akari has selected WuXi XDC, the world’s leading ADC contract development and manufacturing organization (CDMO), as its partner for this critical and necessary IND-enabling work to support the initiation of c

Firmonertinib has the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals Dec. 22, 2025 -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the first patient has

Dec. 22, 2025 -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides and proteins replacement therapies, today announced new validating in vivo pharmacokinetic and pharmacodynamic data that supports further development of a proprietary long-acting parathyroid hormone (PTH) analog using its N-Tab® platform to create the first once-daily tablet treatment for patients with hypoparathyroidism (EB612 program). The positive preclinical findings sh

Dec. 23, 2025 -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID. Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If relevant criteria are met, programs with Fast Track des