Capivasertib in combination with Faslodex granted priority review in the US for patients with advanced hormone receptor positive breast cancer

12 June 2023 - Decision based on CAPItello-291 Phase 3 trial results which showed the combination reduced the risk of ...

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Pharming announces sale of priority review voucher

1 June 2023 - Pharming announces that it has entered into a definitive agreement with Novartis to sell its rare ...

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Iovance Biotherapeutics announces US FDA acceptance of the biologics license application of lifileucel for the treatment of advanced melanoma

26 May 2023 - Priority review granted with PDUFA action date of 25 November 2023. ...

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Takeda and HUTCHMED announce new drug application for fruquintinib for treatment of previously treated metastatic colorectal cancer granted priority review

25 May 2023 - PDUFA target action date set for 30 November 2023. ...

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RegenxBio receives FDA regenerative medicine advanced therapy designation for RGX-121 gene therapy for Hunter syndrome

23 May 2023 - CAMPSIITE trial is enrolling mucopolysaccharidosis type II patients as part of a pivotal program that incorporates ...

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Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy designation for RP-L301 gene therapy for pyruvate kinase deficiency

23 May 2023 - Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...

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US FDA grants priority review of TAK-755 for the treatment of congenital thrombotic thrombocytopenic purpura

16 May 2023 - FDA has granted TAK-755 priority review and rare paediatric disease designation, as well as fast track designation ...

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FDA grants SiSaf’s innovative siRNA therapy SIS-101-ADO orphan drug designation and rare paediatric disease designation for the treatment of autosomal dominant osteopetrosis

15 May 2023 - SiSaf announces that SIS-101-ADO, its siRNA therapeutic, has been granted orphan drug designation and rare paediatric disease ...

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Humacyte’s human acellular vessel receives FDA’s regenerative medicine advanced therapy designation for urgent arterial repair following vascular trauma

4 May 2023 - HAV granted second RMAT designation by the FDA. ...

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FDA accepts Eisai's filing of a supplemental biologics license application and grants priority review for traditional approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer's disease

5 March 2023 - Priority Review accelerates FDA review time with a PDUFA target action on 6 July 2023. ...

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FDA accepts for priority review ADX-2191 new drug application for the treatment of primary vitreoretinal lymphoma

2 March 2023 - PDUFA date is 21 June 2023. ...

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Aflibercept 8 mg BLA for treatment of wet age-related macular degeneration and diabetic macular oedema accepted for FDA priority review

23 February 2023 - BLA supported by two pivotal trials demonstrating non-inferior vision gains to Eylea (aflibercept) Injection, with vast majority ...

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US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

21 February 2023 - US FDA has set an action date for August 2023. ...

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Pozelimab (C5 antibody) BLA for treatment of children and adults with ultra-rare CHAPLE disease accepted for FDA priority review

21 February 2023 - If approved, pozelimab would be the first and only treatment for those living with CHAPLE. ...

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Azafaros receives additional regulatory designations for AZ-3102 from FDA, EMA and MHRA

20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102. ...

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