Latest Headlines

1. 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.

2. 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.

3. 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).

4. 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").

5. 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.

6. 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+).

7. Caliway's CBL-514 Combination Therapy Cleared By U.S. FDA For Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment 8/25/2026

   Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing innovative small-molecule therapeutics, today announced two major clinical milestones in its new drug development program.

8. Vanda Pharmaceuticals Granted Orphan Designation For Imsidolimab For The Treatment Of Generalized Pustular Psoriasis By The European Commission 8/24/2026

   Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that its investigational drug imsidolimab has received Orphan Designation from the European Commission, based on the positive opinion received from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP), for the treatment of Generalized Pustular Psoriasis (GPP), which is a severe, chronic, and potentially life-threatening inflammatory skin disease driven by dysregulation in the interleukin-36 (IL-36) signaling pathway.1

9. Insilico Medicine Convenes O3DC, An Open Consortium For Benchmark Quality In AI-Driven Drug Discovery 8/24/2026

   Insilico Medicine, a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, today announced the launch of the Open Drug Discovery and Development Consortium (O3DC) - o3dc.org, an open initiative addressing how computational drug discovery methods are evaluated, together with its first shared resource: a community-curated index of the benchmarks the field relies on.

10. GC Biopharma's Hunter Syndrome Treatment 'Hunterase' Receives Drug Approval In India And Taiwan 8/24/2026

    GC Biopharma (006280.KS), a leading global pharmaceutical company based in South Korea, announced today that its Hunter syndrome treatment, 'Hunterase IV', has received marketing authorization from India's Central Drugs Standard Control Organisation (CDSCO) and Taiwan's Food and Drug Administration (TFDA). Additionally, 'Hunterase ICV' (brand name in Taiwan: Irifaze ICV), an intracerebroventricular infusion, has also been approved by the Taiwan TFDA.