First-In-Class Archives - Page 6 of 6

Korea Approves the World’s First Cell and Gene Therapy for Knee Osteoarthritis

Approvals, Cell Therapy, FDA/Regulatory, first, First-In-Class, Gene Therapy, Japan, Knee, Korea Ministry of Food and Drug Safety (MFDS), Osteoarthritis, Technology

The Korea Ministry of Food and Drug Safety granted marketing approval for Invossa-K Inj., the world’s first cell and gene therapy for degenerative arthritis.

EU Approves Brineura for CLN2 Disease

Approvals, EMA, European Commission, FDA/Regulatory, First-In-Class, Neuronal Ceroid Lipofuscinosis Type 2 (CLN2), Rare Diseases

The European Commission granted marketing authorization for BioMarin Pharmaceutical’s Brineura for the treatment of tripeptidyl peptidase 1 (TPP1) deficiency.

FDA Grants Fast Track Designation to ContraFect’s CF-301, the First of Its Lysins, Currently in Development for the Treatment of Staph Aureus Infections, Including MRSA

Biotech, Enzymes, Fast Track Designation, FDA/Regulatory, First-In-Class, Health, R&D

YONKERS, NY–(Marketwired – Aug 17, 2015) – ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics and antibody […]