The positive opinion is supported by data from the Phase 3 M20-350 study evaluating the safety and efficacy of MAVIRET® in adults with acute hepatitis C virus (HCV) infection. MAVIRET is a direct-acting antiviral (DAA) treatment currently approved in the European Union for chronic HCV infection in adults and children aged 3 years and older. Acute HCV infection is often asymptomatic, highlighting the importance of early diagnosis and treatment to help reduce transmission, long-term liver-related

PYRUKYND is the only medicine approved in the EU for adults with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia Mitapivat is now approved for thalassemia in the U.S., Saudi Arabia, United Arab Emirates, and EU Avanzanite Bioscience B.V., a specialty pharmaceutical company, will continue to distribute and commercialize PYRUKYND in Europe May 22, 2026 -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering

PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced five upcoming presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) 2026 Congress. The ASCO annual meeting will be held May 29-June 2 in Chicago, and the EH

The FDA has approved the TROP2-directed antibody-drug conjugate Datroway as a first-line option for triple-negative breast cancer, giving Daiichi Sankyo and AstraZeneca a leg up over their competitor Gilead. The approval marks Datroway’s third, after it secured prior approvals in certain HR-positive, HER2-negative breast cancer and lung cancer patients. The latest approval is for metastatic triple-negative breast cancer patients who aren’t candidates for checkpoint inhibitors. The decision was

May 20, 2026 -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the supplemental application for MAIWEIJIAN (Denosumab Injection, R&D code: 9MW0321), which was independently developed by its wholly-owned subsidiary T-mab, has been approved by the National Medical Products Administration (NMPA) for additional indications of bone metastases from solid tumors and multiple myeloma (for the treatment of patients wit

During the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) Oral Explanation, the Company received a “negative trend” opinion for the upcoming June CHMP vote Subject to the formal CHMP vote expected in the June Meeting, the Company plans to request a re-examination procedure for the application MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET)

May 21, 2026 -- Genethon, the French pioneer in the discovery and development of gene therapies for rare diseases, and Ampersand Biomedicines, a Flagship Pioneering multi-product platform company developing smarter medicines that act specifically at the site of disease and nowhere else, announce an exclusive collaboration to engineer a new generation of AAV capsids with superior tissue specificity. This strategic partnership brings together two highly complementary R&D teams with synergistic sci

Dyne Therapeutics (Nasdaq: DYN) has announced the initiation of the Phase III FORZETTO trial of zeleciment rostudirsen (z-rostudirsen; DYNE-251) in Duchenne muscular dystrophy, with the first site now open for enrollment and a biologics license application for US accelerated approval planned for later this quarter. The FORZETTO trial is a global, randomized, double-blind, placebo-controlled Phase III study evaluating z-rostudirsen in approximately 90 ambulatory male participants aged 4 to 18 ye

May 19, 2026 -- Myosin Therapeutics, a clinical stage biotechnology company developing innovative therapies for oncology, today announced that the first patient has been dosed in its Phase 1/2 STAR-GBM study. The trial is designed to assess safety, tolerability, pharmacokinetics, and preliminary signals of clinical activity with longitudinal imaging in adults with newly diagnosed glioblastoma (GBM). With support from the National Cancer Institute (NCI/NIH), the trial is being conducted in collab

IND submission marks Matter Bio's transition toward clinical stage and advances its lead Listeria-based immunotherapy into one of oncology's highest-need indications May 19, 2026 -- Matter Bio today announced the submission of its first Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lm-LLO-TT, the company's lead therapeutic candidate, for a first-in-human Phase 1/2a clinical trial in patients with pancreatic ductal adenocarcinoma (PDAC). If the IN