Chugai's satralizumab receives FDA breakthrough therapy designation for neuromyelitis optica and neuromyelitis optica spectrum disorders

19 December 2018 - Designation is seventh for Chugai originated drug. ...

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Eiger announces breakthrough therapy designation granted by FDA for lonafarnib for treatment of hepatitis delta virus infection

17 December 2018 - Phase 3 HDV “D-LIVR” international study initiating. ...

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Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy application

20 November 2018 - EMA and the US FDA are organising a workshop on 26 November 2018 to discuss how ...

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FDA approves Novartis drug Promacta for first-line SAA and grants breakthrough therapy designation for additional new indication

16 November 2018 - Promacta receives FDA approval for first-line treatment of severe aplastic anaemia and breakthrough therapy designation for low ...

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FDA grants breakthrough therapy designation to Adcetris (brentuximab vedotin) for frontline peripheral T-cell lymphomas

15 November 2018 - Designation based on positive Phase 3 ECHELON-2 Trial evaluating Adcetris in frontline CD30-expressing peripheral T-cell lymphomas. ...

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NeuroRx receives FDA breakthrough therapy designation for NRX-101, first oral drug targeting suicidal bipolar depression

13 November 2018 - First oral rapid-acting anti-depressant to be granted breakthrough designation. ...

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FDA grants breakthrough therapy designation for UroGen Pharma’s UGN-101 for the treatment of patients with low-grade upper tract urothelial cancer

30 October 2018 - On track to initiate rolling submission of UGN-101 new drug application in Q4 2018. ...

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Compass Pathways receives FDA breakthrough therapy designation for psilocybin therapy for treatment-resistant depression

23 October 2018 - Compass Pathways has received breakthrough therapy designation from the US FDA for its psilocybin therapy for ...

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MYR Pharma announces grant of breakthrough therapy designation by US FDA for Myrcludex, the first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections

23 October 2018 - MYR Pharma today announced that US FDA has granted the breakthrough therapy designation for its lead compound ...

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FDA grants breakthrough therapy designation to Kadmon's KD025 for chronic graft-versus-host disease

17 October 2018 - Kadmon Holdings today announced that the U.S. FDA has granted breakthrough therapy designation to KD025, the company’s ...

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Loxo Oncology announces receipt of breakthrough therapy designation from U.S. FDA for LOXO-292 for the treatment of RET fusion-positive thyroid cancer

15 October 2018 - Loxo Oncology today announced that the U.S. FDA has granted breakthrough therapy designation to LOXO-292, a selective ...

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Clovis Oncology receives breakthrough therapy designation for Rubraca (rucaparib) for treatment of BRCA1/2-mutated metastatic castration resistant prostate cancer

2 October 2018 - Breakthrough therapy designation granted to Rubraca based on initial data from on-going TRITON2 Phase 2 study in ...

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Pfizer granted FDA breakthrough therapy designation for 20 valent pneumococcal conjugate vaccine for the prevention of invasive disease and pneumonia in adults aged 18 years ands older

20 September 2018 - Breakthrough therapy designation designed by FDA to expedite the development and review of drugs and vaccines which ...

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FDA grants breakthrough therapy designation for Concentric Analgesics’ CA-008 in post-surgical pain

11 September 2018 - Concentric Analgesics announced today that it has received breakthrough therapy designation from the U.S. FDA) for CA-008 ...

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Tezepelumab granted breakthrough therapy designation by US FDA

7 September 2018 - AstraZeneca’s first breakthrough therapy designation for a respiratory medicine. ...

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