BrainChild Bio's B7 homolog 3 (B7-H3) targeting autologous chimeric antigen receptor (CAR) T-cell therapy, BCB-276, has received the regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for treating diffuse intrinsic pontine glioma (DIPG).
Regenxbio has announced the acceptance of its biologics license application (BLA) by the US Food and Drug Administration (FDA) of its gene therapy clemidsogene lanparvovec (RGX-121) for review to potentially treat Mucopolysaccharidosis II (MPS II), also referred as Hunter syndrome.
InnoCare’s B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has secured breakthrough therapy designation (BTD) from the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE).
The US Food and Drug Administration (FDA) has granted fast track designation to Alterity Therapeutics' oral agent ATH434 for treating multiple system atrophy (MSA).
Roche has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for updating the European Union (EU) label of Phesgo.
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).
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