Novartis’ sickle cell drug gets Breakthrough Therapy designation
Breakthrough Therapy Designation, Novartis, sickle cell
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Breakthrough Therapy Designation
Zogenix gains Breakthrough status, but GW Pharma still ahead in Dravet syndrome
Breakthrough Therapy Designation, Dravet syndrome, Zogenix
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The FDA has granted Zogenix a Breakthrough Therapy Designation for its pipeline product, ZX008 for the treatment of seizures associated with Dravet syndrome.
Novartis adds Promacta to breakthrough status roll-call
Breakthrough Therapy Designation, GlaxoSmithKline, Haematology, Novartis, Promacta, regulation
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Drug could get new indication based on NIH research
Breakthrough status for nephropathy drug lifts Omeros
Breakthrough Therapy Designation, Omeros, Rare diseases
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Enzyvant gains double fast-track for rare disease drug
Breakthrough Therapy Designation, Enzyvant, Rare diseases, Regenerative Medicine Advanced Therapy, Vivek Ramaswamy
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Rebiotix microbiome drug success against C diff infection
Breakthrough Therapy Designation, C diff infection, microbiome, Rebiotix
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Patients suffering from a recurrent C diff infection have benefited from Rebiotix’s microbiome treatment.
New breakthrough designations for Roche’s Alecensa and Actemra
Breakthrough Therapy Designation, cancer, fda, lung cancer, regulation
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Alecensa and Roactemra are breakthroughs, says FDA.
Janssen’s depression drug gains second breakthrough status
Breakthrough Therapy Designation, depression, fda, Janssen
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Drug could help prevent some of the 41,000 suicides every year in US
New Breakthrough status for Darzalex in earlier myeloma treatment
Breakthrough Therapy Designation, Darzalex, multiple myeloma
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Janssen’s drug looking to gain bigger share in crowded myeloma market