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clinical trials

Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis

Zealand Pharma A/S (Nasdaq: ZEAL) today announced that Boehringer Ingelheim has reported that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase 2…

Beyond Celiac Launches First Investment Program for Celiac Disease Therapeutics

Beyond Celiac, the leading catalyst for a cure for celiac disease, today announces the creation of Beyond Celiac Investments (BCI), an investment program to accelerate the development of treatments and a cure for celiac disease by leveraging the speed and…

Numab Therapeutics and Ono Pharmaceutical Announce an Option and Collaboration Agreement to Develop Multi-specific Antibody NM49 for Treatment of Cancer

Numab Therapeutics AG (“Numab”) and Ono Pharmaceutical Co., Ltd. (“Ono”) today announced a global research, development and commercialization collaboration for NM49, a multi-specific antibody designed to activate tumor associated macrophage phagocytosis for the treatment of cancers and identified through Numab’s proprietary…

Sana Biotechnology Announces Publication of Preclinical Diabetes Data in Cell Stem Cell Demonstrating Insulin Independence Following Transplantation of Hypoimmune Allogeneic Primary Islet Cells Without Immunosuppression in a Diabetic NHP

Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that Cell Stem Cell has published a paper titled “Hypoimmune islets achieve insulin independence after allogeneic transplantation in a fully immunocompetent non-human primate.”…

FDA Advisory Committee Votes in Favor of Abbott’s First-of-Its-Kind TriClip™ System to Treat People With a Leaky Tricuspid Heart Valve

Abbott (NYSE: ABT) today announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration (FDA) confirmed 13 to 1, with 0 abstention that the benefits of Abbott’s TriClip™ transcatheter edge-to-edge repair…

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA  

Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with…

BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of…

Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD

Lykos Therapeutics (formerly MAPS Public Benefit Corporation) (“Lykos”), a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration (“FDA”) has accepted its new drug application (“NDA”) for midomafetamine capsules (“MDMA”) used in combination with psychological intervention,…

Hemab Therapeutics Presents Positive Phase 1 Results for HMB-001 in Glanzmann Thrombasthenia at 2024 EAHAD Annual Congress

Hemab Therapeutics, a clinical-stage biotechnology company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, today presented initial results from Phase 1 of its ongoing evaluation of HMB-001. A novel bispecific antibody, HMB-001 is in development as a prophylactic…

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Reports Comments by Strategic Partner Lotus Pharmaceutical Co. Ltd. (1975.TW) in Recent Financial Report

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced that its Asia Pacific strategic partner Lotus Pharmaceutical Co. Ltd (1975.TW) identified enrollment completion of the NRx clinical trial in bipolar depression as a material event in is February…