Please login to the form below

Not currently logged in

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

Latest news

More from news
Approximately 1 fully matching, plus 41 partially matching documents found.

Latest Intelligence

  • 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

More from intelligence
Approximately 0 fully matching, plus 3 partially matching documents found.

COVID-19 Updates and Daily News

Featured jobs


Add my company
Streaming Well

Streaming Well is a healthcare-focused, award-winning video production company which operates in the US and Europe. We create engaging visual...

Latest intelligence

InSite Mapping™ - a Novel Tool for Insight-gathering and Patient Journey Mapping
Learn how a client engaged 18 rheumatologist advisors over 6 months to create a patient journey map for SLE....
Alone we can do so little, together we can do so much
Collaboration is at the heart of successful patient engagement and effective healthcare provision. But in such a complex, nuanced network, true collaborations are rare. So how can we, as an...
7 important considerations for creating an inclusive clinical trial website
You might have noticed that all of us here at COUCH Health are big advocates for taking action to improve diversity and inclusion in the world of clinical research. ‘Taking...