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FDA Approves Personalized Cellular Therapy for Advanced Leukemia
americanpharmaceuticalreview.
September 01, 2017
The U.S. Food and Drug Administration (FDA) approved a personalized cellular therapy developed by the University of Pennsylvania and Children's Hospital of Philadelphia (CHOP) for the treatment of patients up to 25 years of age with B-cell precursor acute
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FDA Approval Brings First Gene Therapy to the U.S.
americanpharmaceuticalreview.
September 01, 2017
The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).
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FDA approves CAR T cell therapy for children with leukaemia
europeanpharmaceuticalreview
September 01, 2017
The FDA has approved CAR T cell therapy for treatment of children with acute lymphoblastic leukemia…
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FDA clears Camber Spine Technologies’ 3D printed medical device
biospectrumasia
September 01, 2017
FDA clears Camber Spine Technologies’ 3D printed medical device This clearance marks Camber’s tenth line of spinal implant systems to be released in the US market and the first to be produced with 3D printing technology.
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FDA approves CAR T cell therapy for kids with leukemia
biospectrumasia
September 01, 2017
St. Baldrick's Foundation plays a key role in bringing this therapy to reality.
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FDA blesses nonprofit-backed Chagas drug, thwarting ex-Shkreli biotech’s bid for rival launch
fiercepharma
August 31, 2017
Parasites found in the feces of triatomine insects, or "kissing bugs," spread Chagas disease.
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The Medicines Co. nets $400M nod for UTI antibacterial treatment
fiercepharma
August 31, 2017
Vabomere's peak sales will hit $400 million in 2028, one analyst predicts.
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FDA fast-tracks recreational drug MDMA for treatment of PTSD
pharmafile
August 31, 2017
In another leap forward for the promising treatment, the FDA has announced that it has granted Breakthrough Therapy Designation to MDMA for the treatment of post-traumatic stress disorder (PTSD).
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FDA approval brings first gene therapy to the United States
worldpharmanews
August 31, 2017
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.
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FDA approves first U.S. treatment for Chagas disease
worldpharmanews
August 31, 2017
The U.S. Food and Drug Administration has granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease.