LifeMax receives rare paediatric disease designation for LM-030 for the treatment of Netherton syndrome

18 July 2019 - LifeMax Laboratories today announced that the FDA granted rare paediatric disease designation to LM-030, an investigational therapy ...

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LogicBio Therapeutics receives rare paediatric disease designation for LB-001 for the treatment of methylmalonic acidaemia

16 July 2019 -  LogicBio Therapeutics today announced the U.S. FDA has granted rare paediatric disease designation to LB-001, a ...

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Caladrius Biosciences receives advanced therapy medicinal product classification for CLBS12, its CD34+ cell therapy for critical limb ischaemia

15 July 2019 - Caladrius Biosciences announced today that the EMA has granted Advanced Therapy Medicinal Product classification to the Company’s ...

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FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab

16 July 2019 - FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises in patients ...

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ViiV Healthcare announces start of first-ever study to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in clinical practice

9 July 2019 - The long-acting injectable regimen has been granted priority review status by the FDA, with a target approval ...

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Priority review granted to BeiGene’s supplemental new drug application in China for tislelizumab in urothelial carcinoma

7 July 2019 - BeiGene today announced that the China National Medical Products Administration has granted priority review status to the ...

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U.S. FDA accepts GSK’s application for Zejula (niraparib) in late stage ovarian cancer with priority review

24 June 2019 - GlaxoSmithKline plc today announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental new ...

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Krystal Biotech receives regenerative medicine advanced therapy designation from FDA for KB103

24 June 2019 - RMAT designation granted to KB103 based on positive interim data from GEM-1 and GEM-2 study. ...

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U.S. FDA accepts supplemental biologics license application for Ultomiris (ravulizumab-cwvz) under priority review for the treatment of atypical haemolytic uremic syndrome

20 June 2019 - FDA sets target action date of 19 October 2019. ...

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FDA grants priority review to Genentech’s Rituxan (rituximab) in children with two rare blood vessel disorders

12 June 2019 - If approved, this would be the first paediatric indication for Rituxan. ...

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Enzyvant announces FDA acceptance of biologics license application and priority review status for RVT-802, a novel investigational tissue-based regenerative therapy for paediatric congenital athymia

5 June 2019 - RVT-802, a one-time therapy, leverages Enzyvant’s T cell generation platform designed to treat profound immunodeficiencies. ...

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Galt Pharmaceuticals answers the call for better practices in pain management with a non-opioid therapeutic alternative

29 May 2019 - Officials with the FDA have given priority review designation to an opioid-free pain management treatment from ...

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U.S. FDA grants priority review for daratumumab in combination with bortezomib, thalidomide and dexamethasone in frontline multiple myeloma

30 May 2019 - 26 September 2019 PDUFA date. ...

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Fibrocell receives FDA regenerative medicine advanced therapy designation for FCX-007 gene therapy for the treatment of RDEB

29 May 2019 - Fibrocell Science today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...

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Avadel Pharmaceuticals announces FDA acceptance of new drug application for AV001

22 May 2019 - AV001 granted priority review. ...

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