SHANGHAI, China — Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for its innovative LILRB4/CD3 TCE bispecific antibody (R&D code: 6MW5311). The drug candidate is being developed for hematologic malignancies, specifically Acute...
Latest News
Cambridge, Mass. – Gene therapy could potentially cure genetic diseases but it remains a challenge to package and deliver new genes to specific cells safely and effectively. Existing methods of engineering one of the most commonly used gene-delivery vehicles, adeno-associated viruses (AAV), are often slow and inefficient. Now, researchers at...
CONSHOHOCKEN, Pa. — Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the Company’s Marketing Authorization Application (MAA) for resmetirom for the treatment of NASH/metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis has been validated and is now under evaluation with the...
CONSHOHOCKEN, Pa. — Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced the publication of the pivotal Phase 3 MAESTRO-NASH trial of resmetirom in the New England Journal of Medicine. NASH is a leading cause of liver-related mortality and an increasing burden...
Positive recommendation based on resmetirom’s favorable profile including positive results from the pivotal Phase 3 MAESTRO-NASH trial European Commission decision expected in August 2025; if approved, resmetirom will be the first medication for people living with MASH in the EU CONSHOHOCKEN, Pa. — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company...
CAMBRIDGE, Mass. – Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, announced today that its Investigational New Drug (IND) application for MGTA-117 is active with the U.S. Food and Drug Administration (FDA). The company...
CAMBRIDGE, Mass. – Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today announced positive preliminary results from its Phase 2 clinical trial of MGTA-145 plus plerixafor in patients with multiple myeloma, which were accepted for presentation...
CAMBRIDGE, Mass. – Magenta Therapeutics, Inc. (Nasdaq: MGTA) today announced that it has received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic...
Roughly 1 out of 15,000 people born suffer from Facioscapulohumeral Muscular Dystrophy (FSHD), a rare disease that starts with the progressive weakening of facial muscles and then the shoulders and upper body. By the time patients reach their 50s, around one-fifth of them are wheelchair bound. Now, a team of...
London, UK – Giving women at risk of premature birth a simple magnesium sulphate infusion (or ‘drip’) can prevent their babies from developing cerebral palsy, a recent Cochrane review has confirmed. The drug itself costs approximately £5 (~$6.50) per dose in England, and requires hospital admission with experienced staff to administer...