Pfizer receives breakthrough therapy designation from FDA for PF-06651600, an oral JAK3 inhibitor, for the treatment of patients with alopecia areata

5 September 2018 - Phase II data accepted for late-breaker news session at 2018 EADV Congress. ...

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Loxo Oncology announces receipt of breakthrough therapy designation from U.S. FDA for LOXO-292

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

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Y-mAbs receives breakthrough therapy designation for naxitamab for the treatment of high risk neuroblastoma

21 August 2018 - Y-mAbs Therapeutics today announced that the company has received a breakthrough therapy designation for naxitamab, in combination ...

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FDA grants breakthrough therapy designation for Xolair (omalizumab) for food allergies

12 August 2018 - There are currently no FDA approved treatments that help prevent severe reactions due to food allergies. ...

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Array Biopharma receives FDA breakthrough therapy designation for Braftovi in combination with Mektovi and cetuximab for BRAF V600E mutant metastatic colorectal cancer

7 August 2018 - Designation based on Phase 3 BEACON CRC safety lead-in data. ...

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FDA and EMA to hold workshop on breakthrough therapy and PRIME designations

2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...

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FDA grants breakthrough therapy designation to Daiichi Sankyo’s FLT3 inhibitor quizartinib for relapsed/refractory FLT3-ITD AML

1 August 2018 - Third breakthrough therapy designation granted by FDA for a compound in the oncology pipeline of Daiichi ...

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Eisai and Merck announce FDA grants breakthrough therapy designation for Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) as therapy for previously treated patients with advanced and/or metastatic non-MSI-H/pMMR endometrial carcinoma

31 July 2018 - Eisai and Merck announced today that the U.S. FDA granted breakthrough therapy designation for Lenvima (lenvatinib), the ...

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FDA grants breakthrough therapy designation for Genentech’s Tecentriq in combination with Avastin as first-line treatment for advanced or metastatic hepatocellular carcinoma

17 July 2018 - Genentech today announced that the U.S. FDA has granted breakthrough therapy designation for Tecentriq (atezolizumab) in combination ...

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Are 'breakthrough' drugs as safe as other FDA approved medicines?

17 July 2018 - New research questions the quality of drugs given the "breakthrough therapy" designation by the US FDA.  ...

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HTX-011 for post-operative pain management receives breakthrough therapy designation from FDA

21 June 2018 - Heron Therapeutics today announced that HTX-011 for post-operative pain management has received breakthrough therapy designation from the ...

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Pfizer's Xalkori (crizotinib) receives FDA breakthrough therapy designation in two new indications

29 May 2018 - Xalkori is the first tyrosine kinase inhibitor to receive breakthrough designation for the treatment of patients ...

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FDA grants breakthrough therapy designation to Lenti-D for the treatment of cerebral adrenoleukodystrophy

23 May 2018 -  bluebird bio today announced that the U.S. FDA has granted breakthrough therapy designation to Lenti-D for ...

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FDA grants breakthrough therapy designation for tafamidis for the treatment of patients with transthyretin cardiomyopathy

23 May 2018 - Pfizer announced today that tafamidis received breakthrough therapy designation from the US FDA for the treatment ...

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Harmony Biosciences receives breakthrough therapy and fast track designations for pitolisant

21 May 2018 - Expanded access program for pitolisant is open and patients are being enrolled. ...

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