This page shows the latest FDA Breakthrough Therapy Designation news and features for those working in and with pharma, biotech and healthcare.
Swiss pharma company Novartis has received a breakthrough therapy designation (BTD) for its experimental medication iptacopan for the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH). ... The European Medicines Agency (EMA) has also granted
Zuranolone already has a breakthrough therapy designation from the US FDA. ... Zuranolone is currently being studied in phase 3 development and has already picked up a breakthrough therapy designation from the US Food and Drug Administration (FDA) for MDD
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
We are very pleased the EMA recognises the transformative potential of PRV-031 and has granted this groundbreaking therapy PRIME designation", said Ashleigh Palmer, CEO of Provention Bio. ... Following on the heels of Breakthrough Therapy Designation
Could challenge rival PARP inhibitor Lynparza. The FDA has granted Johnson &Johnson's PARP inhibitor niraparib a breakthrough therapy designation (BTD) in prostate cancer, helping it to make gains on rival ... We are pleased with the FDA’s Breakthrough
Study shows continued benefit in treatment of rare disease. Last year, Bluebird Bio claimed an FDA breakthrough designation for its Lenti-D gene therapy for cerebral adrenoleukodystrophy (CALD) – it has now ... Lenti-D is Bluebird’s lead gene
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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
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
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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