THOUSAND OAKS, Calif. — Beren Therapeutics P.B.C.®, the parent company of Mandos LLC® and leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for adrabetadex, an investigational cyclodextrin therapy designed to increase intracellular...
treatment News
THOUSAND OAKS, Calif. — Beren Therapeutics P.B.C.® (“Beren”) today announced that its subsidiary Mandos LLC® (“Mandos”) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for adrabetadex, an investigational therapy for the treatment of infantile-onset Niemann-Pick disease type C (NPC). The application was based on data...
BERGEN, Norway — BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced that a poster presentation detailing additional data from a Phase II trial of bemcentinib in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in second line Non-Small Cell...
BerGenBio has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for bemcentinib in combination with an anti-PD-(L)1 agent for the treatment of patients with AXL-positive advanced/metastatic non-small cell lung cancer (NSCLC). The FDA’s decision represents the first recognition by a regulator of AXL-positive patients...
INDIANAPOLIS — A beta blocker typically used to treat heart problems, hemangioma, migraines and anxiety could be a new therapeutic for patients with sickle cell disease. Researchers led by Ankit A. Desai, MD, associate professor of medicine at the Krannert Cardiovascular Research Center (KCVRC) at Indiana University School of Medicine, have been...
MILAN, Italy — BetaGlue® Therapeutics (“BetaGlue” or the “Company”), a pioneering Italian clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, is proud to announce that the Belgium Ministry of Health (MOH) has approved its Clinical Trial Application for YntraDose® in the treatment of unresectable Locally...
SAN FRANCISCO, Calif. — Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic...
TOSSE, France – While Bruton’s tyrosine kinase inhibitors are often hailed as the next big breakthrough in multiple sclerosis, Immunic Therapeutics and others are leveraging neuroprotective targets and remyelination to keep the disease at bay. One of the largest gatherings of multiple sclerosis researchers took place in Barcelona last month,...
HAMILTON, Bermuda — Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. and a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced that the Phase 1 Study evaluating UNO in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and...
– The UK approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date – In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related...