FDA Related News

R3 Selling Unapproved Drugs, Biologics, FDA Says

FDA warns Scottsdale, AZ-based R3 Medical Companies that its Bello Bio and Regen Suppliers units are selling unapproved drugs that are unlicensed biol...

Biologics

FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pediatric patients.

Human Drugs

Create Unified Reference-Anchored Framework for Follow-Ons

Washington State University pharmacy professor Sarfaraz Niazi asks FDA to create an equivalence framework for follow-on human drugs and biologics.

FDA General

Webinar on FDAs Bayesian Draft Guidance

FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics.

Medical Devices

Wearable Device Monitors Ketone Levels and Blood Sugar

FDA grants Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged two ...

Medical Devices

Early Alert on CooperSurgical Neonatal CPAP Ventilator

FDA issues an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal continuous positive ai...

Medical Devices

Roche/Lilly Alzheimers Test Cleared

FDA clears Roche/Eli Lillys Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identifying amyloid pathol...

Biologics

FDA 3-Month Review Extension on Capricor Gene Therapy

FDA extends by three months its review of a Capricor Therapeutics BLA for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy ...

Human Drugs

Study Finds Severe Liver Injury in Small Number of Avacopan Patients

As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study finds that while liver enzyme elevations were unco...

Biologics

Clinical Hold on Regenxbio Hunter Syndrome Gene Therapy

FDA places a clinical hold on Regenxbio's investigational gene therapy RGX-121 after asymptomatic spine MRI findings were identified in five participa...