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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Seattle Genetics and Astellas announce U.S. FDA grants priority review for enfortumab vedotin biologics license application in locally advanced or metastatic urothelial cancer

16 September 2019 - FDA sets Prescription Drug User Fee action date for 15 March 2020. ...

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Horizon Therapeutics announces the FDA has granted priority review of the teprotumumab biologics license application for the treatment of active thyroid eye disease

9 September 2019 - If approved, teprotumumab would be the first FDA approved medicine for this vision-threatening disease. ...

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GBT announces U.S. FDA acceptance of new drug application and priority review for voxelotor for the treatment of sickle cell disease

5 September 2019 - NDA supported by data from Phase 3 HOPE study, which demonstrated statistically significant and sustained improvements in ...

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Magenta Therapeutics announces FDA regenerative medicine advanced therapy designation granted to MGTA-456 for the treatment of inherited metabolic disorders

4 September 2019 - Magenta Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for MGTA-456, ...

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GeneTx and Ultragenyx announce orphan drug designation and rare paediatric disease designation for GTX-102

3 September 2019 - GeneTx Biotherapeutics and Ultragenyx today announced that the U.S. FDA has granted orphan drug designation and rare ...

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AstraZeneca agrees to buy US FDA priority review voucher from Sobi

22 August 2019 - AstraZeneca today announced that it has agreed to buy a US FDA priority review voucher for ...

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U.S. FDA grants Xtandi (enzalutamide) application priority review for the treatment of men with metastatic hormone-sensitive prostate cancer

21 August 2019 - Xtandi supplemental new drug application seeks to add an indication for men with prostate cancer that has ...

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Daré Bioscience receives QIDP designation from the FDA for DARE-BV1 for the treatment of bacterial vaginosis

12 August 2019 - DARE-BV1 Phase 3 registrational trial initiation expected in 4th quarter 2019. ...

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Alnylam announces U.S. FDA granted priority review of the givosiran new drug application for the treatment of acute hepatic porphyria

5 August 2019 - PDUFA date set for 4 February 2020. ...

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Fast track pathways for drug approvals: the Australian experience so far

1 August 2019 - In 2016, the Australian Government announced that the Therapeutic Goods Administration would establish two new pathways ...

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Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)

31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...

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Novartis’ Zolgensma joins growing list of medicines to lose accelerated assessment status in EU

29 July 2019 - The EMA's CHMP recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene ...

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EMA grants PRIME access to ProQR’s sepofarsen for Leber’s congenital amaurosis 10

29 July 2019 - Access based on positive interim analysis of clinical data as well as preclinical data to date. ...

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