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

In a head-to-head psoriatic arthritis trial, UCB's Bimzelx achieved reduced disease activity in 49% of patients vs. 38% of those on AbbVie's Skyrizi. Bimzelx showed numerical superiority in secondary measures, but none that achieved statistical significance. Two months after UCB revealed the success of Bimzelx in a head-to-head trial against AbbVie’s Skyrizi in patients with psoriatic arthritis (PsA), the Belgian drugmaker has unveiled the detailed results. In the phase 3b study that included

Exelixis has secured supplies of subcutaneous Keytruda from Merck & Co. for a planned phase 3 study, completing the trio of contributors needed to run the colorectal cancer trial. California-based Exelixis partnered with Natera on the trial in January. Natera is providing its molecular residual disease (MRD) test for use in the study, as it did for a Roche trial that supported a recent label expansion for Tecentriq. Echoing Roche’s strategy in a different indication, Exelixis will enroll patien

This endocrine essential advances the diagnosis, confirmation and monitoring of Canine Cushing's and Addison's May 19, 2026 -- Dechra is proud to announce the U.S. Food and Drug Administration's (FDA) approval of CosACTHen® (cosyntropin injection), the first and only cosyntropin specifically indicated for use in canine patients. This milestone reinforces Dechra's ongoing commitment to advancing veterinary endocrinology and providing veterinarians with innovative, high-quality solutions for endo

New preclinical data further demonstrate GLIX1's robust efficacy in a dose-dependent manner, with strong anti-tumor activity observed even at the lowest doses tested Results highlight GLIX1's potential to address the high unmet need for patients with GBM May 19, 2026 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing