BioSpace News Archive

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony’s management team will participate in a fireside chat at the upcoming 23rd Annual Needham Virtual Healthcare Conference on Monday, April 8, 2024, at 9:30 a.m. ET.

STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit has been granted de novo classification by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.

Indivi, a leading MedTech company headquartered in Basel, Switzerland, has entered into an agreement with Biogen to advance digital health technology and develop digital biomarkers for Parkinson’s disease.

Technology from TriSalus Life Sciences® Inc. (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, was featured in two oral presentations at the Society of Interventional Radiology Annual Scientific Meeting.

Tenon Medical, Inc. (NASDAQ:TNON) (“Tenon” or the “Company”), a company transforming care for patients suffering with certain sacroiliac joint disorders, today announced significant progress in the post-market study utilizing the Company’s Catamaran® SI Joint Fusion System.

Modular Medical, Inc., a development-stage, insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, announced the addition of Steve Gemmell as Vice President of Engineering.

IntraBio Inc today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for IB1001 for the treatment of Niemann-Pick disease Type C (NPC).

Takeda (TSE: 4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of ADZYNMA (apadamtase alfa /cinaxadamtase alfa) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older.

Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics to elicit a potent and durable immune response, today announced the appointments of Jeltje Schulten, M.D., MBA, as SVP of clinical and medical affairs and Rita Dalal, MBBS, MPH, as vice president of clinical development.

CinFina Pharma, a CinRx portfolio company dedicated to advancing a portfolio of high-impact treatment options for obesity and metabolic diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application (IND) for CIN-110, a PYY3-36 analog, allowing the first in-human clinical study to proceed.