Newron receives FDA rare paediatric disease designation for sarizotan for the treatment of Rett syndrome

19 November 2019 - Newron announced today that the U.S. FDA has granted the rare paediatric disease designation for sarizotan, ...

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Medexus granted priority review status for Gliolan by Health Canada

19 November 2019 - Medexus Pharmaceuticals today announced that Health Canada has granted priority review status for the new drug ...

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European Medicines Agency grants Orchard Therapeutics accelerated assessment of OTL-200 for patients with metachromatic leukodystrophy

18 November 2019 - Orchard Therapeutics today announced that the CHMP of the EMA has granted an accelerated assessment for OTL-200, ...

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Anavex Life Sciences receives rare paediatric disease designation from FDA for Anavex 2-73 (blarcamesine) for the treatment of Rett syndrome

14 November 2019 - Anavex Life Sciences today announced that it received the rare paediatric disease designation from the U.S. FDA ...

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US FDA accepts regulatory submission for selumetinib in neurofibromatosis type 1 and grants priority review

14 November 2019 - AstraZeneca and MSD’s selumetinib would become the first medicine indicated for the treatment of paediatric patients with ...

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Allergan receives FDA qualified infectious disease product designation and fast track designation for ATM-AVI (aztreonam and avibactam) for antibiotic-resistant gram-negative infections

11 November 2019 - FDA QIDP and fast track designations signify significant milestones in Allergan commitment to addressing unmet medical needs ...

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CARsgen announces investigational CAR-T therapy CT053 granted RMAT designation by the U.S. FDA for relapsed/refractory multiple myeloma

28 October 2019 - CARsgen Therapeutics today announced that the United States FDA has granted regenerative medicine advanced therapy designation to ...

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Trastuzumab deruxtecan (DS-8201) granted FDA priority review for treatment of patients with HER2 positive metastatic breast cancer

17 October 2019 - Daiichi Sankyo and AstraZeneca today announced that the U.S. FDA has accepted for review the biologics ...

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ProQR receives rare paediatric disease designation from FDA for sepofarsen for the treatment of LCA10

15 October 2019 - ProQR Therapeutics today announced that it received rare paediatric disease designation from the U.S. FDA for ...

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Emergent BioSolutions receives EMA Prime Designation for its Chikungunya virus vaccine candidate

10 October 2019 - Emergent BioSolutions today announced that the company’s chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, ...

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Vast Therapeutics receives qualified infectious disease product status for BIOC11

8 October 2019 -  Vast Therapeutics today announced that another of its drug candidates, BIOC11, has been designated as a ...

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Fees for redeeming priority review vouchers fall to all-time low in FY2020

30 September 2019 - The US FDA on Friday announced the fees for using a priority review voucher to speed ...

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FDA grants paediatric disease designation for Mateon's OT101

23 September 2019 - For treatment of diffuse intrinsic pontine glioma, a difficult to treat form of childhood brain tumour. ...

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SanBio granted regenerative medicine advanced therapy designation from the U.S. FDA for SB623 for the treatment of chronic neurological motor deficits secondary to traumatic brain injury

19 September 2019 - The SanBio Group today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...

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FDA accepts Merck’s biologics license application and grants priority review for V920, the company’s investigational vaccine for Ebola Zaire virus

17 September 2019 - Merck continues to expand investigational supply to support international Ebola outbreak response. ...

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