Priority review granted to Ascentage Pharma's new drug application for olverembatinib (HQP1351), the first third generation BCR-ABL inhibitor in China

21 October 2020 - Ascentage Pharma today announced that the Center for Drug Evaluation of China's National Medical Products Administration has ...

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Selecta Biosciences and AskBio receive FDA rare paediatric disease designation for their gene therapy for methylmalonic acidemia

20 October 2020 - Selecta Biosciences and Asklepios BioPharmaceutical today announced the U.S. FDA has granted rare paediatric disease designation to ...

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Tagrisso granted priority review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer

20 October 2020 - Unprecedented results show treatment with Tagrisso reduced the risk of disease recurrence or death by 80% in ...

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U.S. Food and Drug Administration accepts for priority review applications for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) in advanced renal cell carcinoma

19 October 2020 - U.S. Food and Drug Administration assigned a target action date of 20 February 2021. ...

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Versantis receives FDA rare paediatric disease designation for VS-01 for the treatment of urea cycle disorders

19 October 2020 - Versantis today announced that the U.S. FDA has granted a rare paediatric disease designation to its lead ...

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Taysha Gene Therapies receives rare paediatric disease designation and orphan drug designation for TSHA-102 as a treatment for Rett syndrome

14 October 2020 - Program leverages novel miRARE platform technology used to control transgene expression on a cellular basis. ...

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Oxular receives rare paediatric disease and orphan drug designations for retinoblastoma treatment

12 October 2020 - Provides furthered momentum for OXU-003 development programme. ...

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Axovant Gene Therapies receives rare paediatric disease designation for AXO-AAV-GM1 for GM1 gangliosidosis

9 October 2020 - Company on-track to report data from on-going Phase 1/2 clinical study in Q4 2020. ...

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Italfarmaco receives FDA rare paediatric disease designation for givinostat in Duchenne muscular dystrophy, announces completed enrolment in EPIDYS Phase 3 trial

9 October 2020 - The Italfarmaco Group provided today an update on the development of givinostat, its proprietary histone deacetylase ...

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U.S. FDA grants rare paediatric disease designation to Cerecin’s investigational drug tricaprilin for the treatment of infantile spasms

8 October 2020 - Cerecin announced that the U.S. FDA has granted rare paediatric disease designation to tricaprilin, an investigational drug ...

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Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study

7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...

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Y-mAbs’ nivatrotamab for the treatment of patients with neuroblastoma granted orphan drug designation and rare paediatric disease designation by FDA

7 October 2020 - Y-mAbs Therapeutics today announced that the FDA has granted orphan drug designation and rare paediatric disease ...

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Oncternal Therapeutics receives rare paediatric disease designation from U.S. FDA for TK216 for treatment of Ewing sarcoma

6 October 2020 - Oncternal Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for TK216, an ...

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Aegle Therapeutics receives rare paediatric disease designation from the FDA for AGLE-102 for patients with dystrophic epidermolysis bullosa

6 October 2020 - -- Aegle Therapeutics today announced that the FDA has granted rare paediatric disease designation to ...

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FDA announces all time low rates for FY2021 priority review vouchers

5 October 2020 - The US FDA has announced historic low rates for the fiscal year 2021 fees to use ...

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