While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...

The firm said the agency cited chemistry, manufacturing, and controls issues in its complete response letter, but had no concerns about product quality.

In his first 100 days as commissioner of the Food and Drug Administration, Marty Makary has made a handful of splashy ...

As predicted the era of universal newborn genomic screening is dawning. The UK and Florida are leading the way.

CRISPR Therapeutics is revolutionizing medicine with gene editing. Learn more about CRSP's breakthroughs, stock rally, and ...

Emerging oligonucleotides and gene editing therapies offer greater precision, long-term efficacy, and improved adherence in comparison to traditional statin therapies.

This gene therapy for patients suffering from otoferlin deficiency has been developed in the framework of RHU AUDINNOVE, a consortium composed of Sensorion with the Necker Enfants Malades Hospital ...

In this article, we review approved gene therapies and current preclinical gene therapy studies with an emphasis on nanoparticle mediated gene therapy in women’s health. Additionally, we discuss ...

— Approval based on Phase III SACHI Trial results which showed a 66% reduced risk of progression or death as compared to platinum-based chemotherapy — — The only all-oral combination ...

Ferring Pharmaceuticals officially opened doors to its state-of-the-art gene therapy manufacturing facility in Parsippany June 17.