Latest Headlines

  1. Karyopharm Submits Supplemental New Drug Application To The FDA For XPOVIO® (Selinexor) Plus Ruxolitinib For Patients With Myelofibrosis 8/31/2026

    Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking Accelerated Approval for XPOVIO® (selinexor) in combination with ruxolitinib for patients with myelofibrosis.

  2. Ascletis Announces First Participant Dosed In A Global Phase III Clinical Program Of Once-Daily Oral Small Molecule GLP-1 Receptor Agonist ASC30 For Chronic Weight Management 8/30/2026

    Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announced that the first participant has been dosed in a global Phase III clinical program of ASC30 for chronic weight management. ASC30 is an investigational, proprietary once-daily oral small molecule glucagon-like peptide-1 receptor (GLP-1R) agonist being developed for chronic weight management and diabetes.

  3. Clicklinks | Sanyou Bio Launches Clicklinks, An AI-Driven Innovation Hub For Original Drug Discovery 8/28/2026

    Sanyou Biopharmaceuticals Co., Ltd. (hereinafter referred to as "Sanyou Bio"), today announced the official launch of Clicklinks, an AI-STAL and SAI-DA powered collaborative network designed to support original drug discovery and preclinical development.

  4. New Drug Application For 'K-911' Targeting Patients With Glaucoma And Ocular Hypertension Accepted For Filing In The U.S., Food And Drug Administration 8/27/2026

    Kowa Company, Ltd. (hereafter referred to as "Kowa") is developing K-911 for the indication of reducing intraocular pressure (IOP) in patients with glaucoma or ocular hypertension through its affiliated company engaged in pharmaceutical development in the United States, Kowa Research Institute, Inc. (headquartered in North Carolina, USA).

  5. Artis BioSolutions Launches mRNA And Lipid Nanoparticle Manufacturing Capabilities At New 'Genetic Medicines Center Of Excellence' In Bilbao, Spain 8/26/2026

    Artis BioSolutions, a company founded to streamline the discovery, development, and production of genetic medicines, today announced the launch of its Genetic Medicines Center of Excellence in Bilbao, Spain.

  6. HepaRegeniX Receives Orphan Drug Designation For Darizmetinib For The Prevention Of Post-Hepatectomy Liver Failure 8/26/2026

    HepaRegeniX GmbH (“HepaRegeniX”), a clinical-stage biotech company advancing novel therapies for acute and chronic liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to darizmetinib (formerly HRX215) for the prevention of post-hepatectomy liver failure.

  7. ReviR Therapeutics Receives FDA Rare Pediatric Disease Designation For RTX-117 In Charcot-Marie-Tooth Disease 8/26/2026

    ReviR Therapeutics, a clinical-stage biotechnology company advancing small-molecule therapies through the integration of artificial intelligence and RNA biology, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to RTX-117, the company's investigational oral small-molecule candidate, for its development in Charcot-Marie-Tooth disease (CMT).

  8. SK Biopharmaceuticals To In-License Epilepsy Drug Candidate 'Opakalim' 8/26/2026

    SK Biopharmaceuticals Co., Ltd. (www.skbp.com/ CEO: Donghoon Lee) held a press conference on August 26th and announced that it has entered into an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven Ltd. and/or its wholly owned subsidiaries ("Biohaven").

  9. AI Drug Discovery Leaders Gain A Competitive Edge With Telesis Bio's Gibson SOLA Platform, Generating Development Candidates Faster 8/25/2026

    Telesis Bio Inc., maker of the world’s only intelligent, on-premises DNA synthesis solution for AI labs, today announced recent commercial licensing agreements with several AI-native drug discovery companies.

  10. U.S. FDA Approves Ziihera® (zanidatamab-hrii) With And Without Tislelizumab Plus Chemotherapy In First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma 8/25/2026

    Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced that its partner, Jazz Pharmaceuticals, has received U.S. Food and Drug Administration (FDA) approval for two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive (HER2+) gastroesophageal adenocarcinoma (GEA): Ziihera plus Tevimbra® (tislelizumab-jsgr) and fluoropyrimidine- and platinum-containing chemotherapy (HER2+ IHC 3+ and IHC 2+/ISH+), and Ziihera plus fluoropyrimidine- and platinum-containing chemotherapy (HER2+ IHC 3+).