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FDA Breakthrough Therapy Designation

This page shows the latest FDA Breakthrough Therapy Designation news and features for those working in and with pharma, biotech and healthcare.

BMS/bluebird bio resubmit FDA application for myeloma CAR-T

BMS/bluebird bio resubmit FDA application for myeloma CAR-T

J&J picked up a breakthrough therapy designation (BTD) from the FDA last year for its candidate, JNJ-4528, after the therapy demonstrated impressive results in a phase 1b/2 study ... in multiple myeloma patients who had received at least three prior

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  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... The sickle cell programme has also been named on the FDA’s Regenerative

  • Deal Watch February 2017 Deal Watch February 2017

    IMMU-132 has FDA Breakthrough Therapy designation for the treatment of patients with TNBC who have failed prior therapies for metastatic disease and also has Fast Track status and orphan designation ... Licence. 145. Sarepta Therapeutics/  Gilead

  • Interview: AstraZeneca's Susan Galbraith Interview: AstraZeneca's Susan Galbraith

    What selumetinib does is potentially deliver a new targeted therapy into an area where there aren't any targeted therapies,” says Galbraith. ... This drug has recently received Breakthrough Therapy designation from the US FDA and phase 1 data will be

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