Genentech Reports Positive Phase III Krascendo 1 Results Demonstrating Divarasib Improves Survival in Previously Treated KRAS G12C Non-Small Cell Lung Cancer Genentech, a member of the Roche Group, has announced positive topline results from its pivotal Phase III Krascendo 1…
Rezon Bio Appoints Dr. Hubert Scholze as Chief Business Officer to Drive Global Growth and Strengthen Biologics CDMO Capabilities Rezon Bio, a science-driven European contract development and manufacturing organization (CDMO) specializing in biologics, has announced the appointment of Dr. Hubert…
Croma-Pharma Secures FDA Approval for Obagi saypha® ChIQ™ to Expand Facial Aesthetic Treatment Options in the U.S. Croma-Pharma has reached another significant milestone in its global growth strategy with the U.S. Food and Drug Administration (FDA) approving Obagi saypha® ChIQ™,…
Hengrui’s Heng Yi® Approved in China for Dry Eye Disease Treatment Hengrui Pharma and Novaliq GmbH have announced that China’s National Medical Products Administration (NMPA) has approved Heng Yi® (0.1% cyclosporine ophthalmic solution) for the treatment of patients with dry…
Novocure Secures CE Mark for Optune Pax in Locally Advanced Pancreatic Cancer Novocure has achieved a significant regulatory milestone after receiving the CE (Conformité Européenne) Mark for Optune Pax®, authorizing the device for the treatment of adult patients with locally…
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)…