US FDA grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma

21 January 2020 - Belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients. ...

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Lynparza regulatory submission granted priority review in the US for HRR-mutated metastatic castration-resistant prostate cancer

20 January 2020 - Submission based on PROfound, the first positive Phase III trial testing a targeted treatment in biomarker-selected ...

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Fortress Biotech announces rare paediatric disease designation for CUTX-101 for the treatment of Menkes disease

16 January 2020 - Cyprium Therapeutics, a Fortress partner company, on track to begin submitting rolling new drug application for CUTX-101 ...

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Clovis Oncology’s Rubraca (rucaparib) granted FDA priority review for advanced prostate cancer

15 January 2020 - FDA has assigned PDUFA date of 15 May 2020. ...

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U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line non-small cell lung cancer

15 January 2020 - Application based on results from Part 1 of Phase 3 CheckMate-227 study. ...

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Lynparza regulatory submission granted priority review in the US for first-line maintenance treatment with bevacizumab in advanced ovarian cancer

13 January 2020 - Submission based on Phase III PAOLA-1 trial for patients with advanced ovarian cancer regardless of biomarker ...

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Aruvant receives FDA rare paediatric disease designation for ARU-1801 for the treatment of sickle cell disease

8 January 2020 - ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and ...

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Farxiga granted FDA priority review for patients with heart failure with reduced ejection fraction

6 January 2020 - AstraZeneca today announced the US FDA has accepted a supplemental new drug application and granted Priority ...

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European Medicines Agency validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A

23 December 2019 - Potential first gene therapy in Europe directed at any type of haemophilia. ...

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Chondrial Therapeutics announces dosing of first patients in Phase 1 clinical program of CTI-1601 for treatment of Friedreich’s ataxia; CTI-1601 granted rare pediatric disease designation and fast track designation by U.S. FDA

18 December 2019 - Chondrial Therapeutics, a clinical-stage biotechnology company focused on developing treatments for rare diseases, with an initial ...

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Rocket Pharmaceuticals receives EMA PRIME eligibility for RP-L102 gene therapy for Fanconi anaemia

16 December 2019 - Milestone gives Fanconi anaemia program all accelerated regulatory tools in U.S. and EU, including FDA regenerative medicine ...

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Y-mAbs’ GD2-GD3 vaccine granted rare paediatric disease designation

12 December 2019 - Y-mAbs Therapeutics today announced that its GD2-GD3 vaccine has been granted a rare paediatric disease designation ...

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Health Canada grants priority review status for Heron Therapeutics' new drug submission for HTX-011 for management of post-operative pain

3 December 2019 - Heron Therapeutics today announced that Heron's new drug submission for HTX-011 for the management of postoperative pain ...

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Regenerative medicine advanced therapy designation granted by FDA to ADP‑A2M4 for the treatment of synovial sarcoma

3 December 2019 - Will enable expedited development and review of ADP-A2M4 with the goal of commercialisation in 2022 for patients ...

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FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC)

2 December 2019 - Application based on results from Phase 2 KEYNOTE-057 trial, to be discussed at December FDA Oncologic Drugs ...

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