Abeona Therapeutics has announced receipt of the US Food and Drug Administration (FDA) approval for gene-modified cellular sheet therapy Zevaskyn for the wound treatment in both adult and paediatric patients suffering from recessive dystrophic epidermolysis bullosa (RDEB), a serious genetic skin condition.
The European Medicines Agency (EMA) has granted orphan drug designation to UK-based Purespring Therapeutics’ lead candidate, PS-002, aimed at treating IgA nephropathy (IgAN).
The National Institute for Health and Care Excellence (NICE) has issued final guidance endorsing Pharming Group’s Joenja (leniolisib) for use and reimbursement in the National Health Service (NHS) in England and Wales.
Ensem Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for ETX-636.
Viatris has submitted applications to Japan's Ministry of Health, Labor and Welfare (MHLW) for the approval of Effexor SR Capsules (venlafaxine hydrochloride) to treat adults with generalised anxiety disorder (GAD).
ALX Oncology has received investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) for ALX2004, a new antibody-drug conjugate (ADC) aimed at treating solid tumours that express the epidermal growth factor receptor (EGFR).
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Amgen’s humanised monoclonal antibody Uplizna (inebilizumab-cdon) to treat the adult population with immunoglobulin G4-related disease (IgG4-RD), an immune-mediated inflammatory condition that impacts several organs.
The US Food and Drug Administration (FDA) has granted clearance for an investigational new drug (IND) application of Epicrispr Biotechnologies’ EPI-321, intended for treating genetic neuromuscular condition, facioscapulohumeral muscular dystrophy (FSHD).
Biogen has received fast track designation from the US Food and Drug Administration (FDA) for its investigational antisense oligonucleotide (ASO) therapy, BIIB080, to treat Alzheimer's disease.
Pharvaris has secured orphan designation from the European Commission (EC) for deucrictibant, an investigational drug for treating bradykinin-mediated angioedema.
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