Kriya Therapeutics Selected for FDA PreCheck Pilot Program to Advance U.S. Gene Therapy Manufacturing Kriya Therapeutics, Inc., a biotechnology company focused on developing durable gene therapies for chronic diseases, has announced that it has been selected by the U.S. Food…
Enhertu Gains EU Approval for Previously Treated HER2-Positive Solid Tumours AstraZeneca and Daiichi Sankyo have announced that the European Commission (EC) has approved Enhertu® (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive…
DePuy Synthes Appoints Christina Zamarro as Chief Financial Officer to Support Continued Global Growth DePuy Synthes, a global leader in orthopaedic technologies and solutions, has announced the appointment of Christina Zamarro as its new Chief Financial Officer (CFO), effective July…
SKYRIZI® Gains FDA Approval for Use in Children with Psoriatic Disease AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of children aged six years and older with moderate-to-severe plaque psoriasis…
CHMP Recommends EU Approval of DAYBUE® (trofinetide) Acadia Pharmaceuticals Inc. has announced a significant regulatory milestone for its rare disease portfolio after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive…
Trodelvy® is now FDA-approved as a first-line treatment option for patients with metastatic triple-negative breast cancer, expanding its role in frontline care. Gilead Sciences has secured a major new U.S. regulatory milestone for Trodelvy (sacituzumab govitecan-hziy), with the U.S. Food…
TRYNGOLZA® becomes the first and only FDA-approved treatment for severe hypertriglyceridemia, reducing both triglyceride levels and the risk of acute pancreatitis. Ionis Pharmaceuticals has secured a major regulatory milestone with the U.S. Food and Drug Administration’s approval of TRYNGOLZA (olezarsen)…
Pfizer’s IBRANCE Wins FDA Approval in HR+/HER2+ Metastatic Breast Cancer, Expanding CDK4/6 Use Into New Maintenance Setting Pfizer has secured a significant new U.S. regulatory milestone for IBRANCE (palbociclib), with the U.S. Food and Drug Administration approving the CDK4/6 inhibitor…
EMD Serono Names Miguel Fernández Alcalde Head of Global Commercial Strategy, Appoints Monia Vial to Lead North America EMD Serono, the Healthcare business of Merck KGaA in the United States and Canada, has announced a significant leadership transition that reshapes…
Alpha Cognition Appoints Robert Wills as Chairman of the Board as Company Advances ZUNVEYL Launch and Neurodegenerative Pipeline Alpha Cognition Inc. has announced a key leadership transition at the board level, naming Robert Wills as its new Chairman of the…
Arrowhead Pharmaceuticals Wins EU Approval for REDEMPLO® to Lower Triglycerides in Adults with Familial Chylomicronemia Syndrome Arrowhead Pharmaceuticals has secured an important regulatory milestone in Europe with the European Commission’s marketing authorization of REDEMPLO® (plozasiran) for adults living with familial…
Syntax Bio Expands Series A to $14.4 Million, Strengthens Leadership Team and Advances Cell Programming Platform for Type 1 Diabetes Therapies Syntax Bio, a synthetic biology company focused on programming the next generation of cell therapies, has announced a significant…