MedCity News

FDA Pilot Program Creates New Path for Faster Regulatory Review of Generic Drugs

Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...
Business Insider

Emergent BioSolutions Receives U.S. FDA Approval for Drug Product Manufacturing of raxibacumab at its Winnipeg, Canada Site

GAITHERSBURG, Md., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License ...
Seeking Alpha

FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness

– Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME) – – With as few as two treatments per year, ...
Morningstar

VGXI Completes Successful FDA Inspection Enabling Client BLA Approval Milestone, Advancing Its Leadership in Plasmid DNA Manufacturing

CONROE, Texas, May 13, 2025 /PRNewswire/ -- VGXI, Inc., a leading contract development and manufacturing organization (CDMO) specializing in plasmid DNA biopharmaceuticals, including for use in gene ...
Medscape

FDA Approves First Implantable Continuous Glucose Monitor

The US Food and Drug Administration (FDA) has approved the first-ever implantable continuous glucose monitoring system, the Eversense CGM (Senseonics), for people aged 18 years and older with diabetes ...