FDA

Samsung partnered with Lunit on AI for Enhanced Chest Screening On January 25, 2024, Samsung entered into a supply collaboration with Lunit, in order to employ its AI-powered technology for conducting chest screenings.  The agreement was signed by Boston Imaging, which serves as the U.S. hub for Samsung's d...

Merck’s KEYTRUDA Reduced the Risk of Death by 38% Versus Placebo as Adjuvant Therapy for Patients With Renal Cell Cancer (RCC) at an Increased Risk of Recurrence Following Nephrectomy Merck, also known as MSD beyond the United States and Canada, has revealed findings from the Phase III KEYNOTE-564 trial, which a...

Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™ Pi-Cardia Ltd., a prominent player in advancing catheter-based leaflet modification solutions for heart valve treatment, revealed that its ShortCut™ device has attained Breakthrough Device Designation from the US Food and Drug Administration. S...

Opdivo in Combination with CABOMETYX Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma Bristol Myers Squibb and Exelixis, Inc. have released the four-year follow-up findings from the CheckMate -9ER trial, which investiga...

From January 8th to 11th, 2024, the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) took center stage in San Francisco, CA, USA. Spanning four dynamic days, this conference saw the active participation of prominent figures from major pharmaceutical, biotechnology, Medtech, HealthTech entities, and emerging fa...

Bayer’s AskBio initiates Phase II GenePHIT trial in Congestive Heart Failure Merck, also recognized as MSD in regions beyond the United States and Canada, has officially announced that the FDA has approved for the use of KEYTRUDA, Merck's anti-PD-1 therapy, in conjunction with chemoradiotherapy (CRT) for treatin...

Lutikizumab Showed Positive Results in a Phase II Trial of Adults with Moderate to Severe Hidradenitis Suppurativa as Program Advances to Phase III AbbVie has reported the results of Phase II trials indicating that adults experiencing moderate to severe hidradenitis suppurativa, and who had previously not respon...

Cytokinetics Announces Positive Results From SEQUOIA-HCM, the Pivotal Phase III Clinical Trial of Aficamten in Patients With Obstructive Hypertrophic Cardiomyopathy Cytokinetics, Incorporated released favorable top-line findings from the SEQUOIA-HCM trial (Safety, Efficacy, and Quantitative Understanding of Obst...

ImPact Biotech Receives FDA Clearance of IND Application for Padeliporfin VTP in Pancreatic Cancer ImPact Biotech, a biotechnology company in its clinical stage dedicated to advancing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for various solid tumors, announced on December 20, 2023, that the U.S....

Eisai Submits Marketing Authorization Application In Japan for Anticancer Agent Tasurgratinib For Biliary Tract Cancer With FGFR2 Gene Fusion Eisai Co., Ltd. has officially submitted a request for marketing authorization in Japan for tasurgratinib succinate, its internally developed tyrosine kinase inhibitor tar...