Cipla’s Pithampur Facility Receives 7 FDA Observations Following Inspection
Cipla Limited announced the conclusion of a routine Current Good Manufacturing Practice (cGMP) inspection conducted by the United States Food and Drug Administration (US FDA)...
Roche Wins FDA Clearance for New Blood Test to Detect Alzheimer’s Disease
Roche has secured U.S. Food and Drug Administration clearance for Elecsys pTau217, a plasma-based blood test designed to help physicians detect amyloid pathology linked to Alzheimer's...
FDA Grants Approval to Johnson & Johnson’s IMAAVY for Warm Autoimmune Hemolytic Anemia
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY® (nipocalimab-aahu) as the first therapy specifically indicated for the...
FDA Approves World’s First Combined Glucose-Ketone Wearable Monitor
The U.S. Food and Drug Administration has granted marketing authorization to Abbott Diabetes Care for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System,...
Lundbeck and EVERSANA Enter Strategic Partnership to Advance AI-Powered Commercialization Across U.S. Operations
Lundbeck, a global biopharmaceutical leader focused exclusively on brain health, and EVERSANA®, a leading global provider of commercial services to the life sciences sector,...
Montage Laboratories Commences Construction of Manufacturing Unit 3 to Expand Production Footprint
Montage Laboratories Pvt. Ltd., a manufacturer of pharmaceutical formulations, has performed the Bhoomi Pujan(groundbreaking ceremony) for its upcoming manufacturing facility, Unit 3. The milestone marks a new phase in the...
