Breakthrough Therapy Designation | pharmaphorum

Breakthrough Therapy Designation

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Red blood cells

Novartis' sickle cell drug gets Breakthrough Therapy designa...

The FDA has granted Breakthrough Therapy designation to Novartis' crizanlizumab for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with

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Zogenix

Zogenix gains Breakthrough status, but GW Pharma still ahead...

The FDA has granted Zogenix a Breakthrough Therapy Designation for its pipeline product, ZX008 for the treatment of seizures associated with Dravet syndrome.

Novartis

Novartis HQ

Novartis adds Promacta to breakthrough status roll-call

Novartis’ Promacta has been given Breakthrough Therapy Designation by the FDA for previously untreated patients with severe aplastic anaemia (SAA).

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Will Gottlieb follow up on Trump's promise of a bonfire of regulations?

Breakthrough status for nephropathy drug lifts Omeros

The FDA has given breakthrough therapy designation to OMS721, a new treatment for the

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enzyvant

Enzyvant gains double fast-track for rare disease drug

Switzerland-based biopharma start-up Enzyvant has gained a double fast track status from the FDA for its new rare disease candidate RVT-802.

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Rebiotix microbiome drug success against C diff infection

Patients suffering from a recurrent infection with the C difficile bacteria have benefited from a microbiome treatment from Rebiotix.