US FDA approves Vertex's gene therapy for sickle cell disease in children as young as two

July 1 (Reuters) - The U.S. Food and Drug Administration approved expanded use of Vertex Pharmaceuticals' gene therapy in ...

FDA staff question peptides backed by Kennedy ahead of advisory panel review

By Sneha S K June 30 (Reuters) - U.S. FDA staff reviewers said there is little evidence to allow compounding pharmacies to ...

US FDA declines to approve Unicycive's kidney disease drug

By Padmanabhan Ananthan June 30 (Reuters) - Unicycive Therapeutics said on Tuesday the U.S. drug regulator has declined to ...

Galderma hits FDA setback again in bid to launch Botox rival in US

Shares dropped after the skincare group failed to secure approval for its latest antiwrinkle treatment, a potential rival to ...

FDA U-turns on rare disease treatment: what it means for patients

A first-of-its-kind drug may slow the progression of Huntington's disease, a rare, fatal, neurodegenerative disorder.

US FDA issues 'Modified Risk Tobacco Product Orders' for 20 ZYN Nicotine pouch products

Philip Morris International Inc announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco ...

US FDA approves Orca Bio's blood cancer therapy

June 30 (Reuters) - The U.S. Food and Drug Administration has approved Orca Bio's cell therapy for the treatment of certain ...
Las Vegas Sun

Orca Bio’s TREGZI™ Receives U.S. FDA Approval as First and Only Precision-Engineered Cell Therapy for Allogeneic Transplant in Adults with Hematological Malignancies

Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the U.S. Food and Drug Administration (FDA) has ...
NC Biotech

FDA selects 3 NC sites for pilot program to boost US biomanufacturing

The U.S. Food and Drug Administration selected three biopharma companies with manufacturing sites in North Carolina for a ...