FDA

Breakthrough for Pharma Industry & Patients
Features
Breakthrough for Pharma Industry & Patients - FDA Approved Gene Transfer Therapy
On 30 August, the US Food and Drug Administration (FDA) approved Novartis's Kymriah (tisagenlecleucel, CTL019), the first gene therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Kymriah belongs to a class of drugs called chimeric antigen receptor (CAR) T-cell therapies, which constitute a form of immunotherapy...
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Drug Shortages Prevention Plan Released

15 October 2014
News & Press Releases
ISPE released its Drug Shortages Prevention Plan yesterday during 2014 Annual Meeting in Las Vegas, Nevada. Regulators from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Medicines and Healthcare Products...