Approvals

UK MHRA approves Vertex’s Alyftrek for cystic fibrosis

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Vertex Pharmaceuticals’ triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), for treating cystic fibrosis (CF) in individuals aged six years and above.

FDA approves Celltrion’s biosimilars for various indications

The US Food and Drug Administration (FDA) has approved Celltrion’s Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), the biosimilars referencing Amgen’s Prolia and Xgeva, respectively.

FDA grants fast track status for Avobis’ AVB-114

The US Food and Drug Administration (FDA) has granted fast track designation for Avobis Bio’s lead therapeutic candidate, AVB-114, for treating Crohn's perianal fistulas.

US FDA approves Deciphera’s Romvimza for TGCT treatment

The US Food and Drug Administration (FDA) has granted approval for Deciphera Pharmaceuticals’ Romvimza (vimseltinib) to treat adults with symptomatic tenosynovial giant cell tumour (TGCT).

FDA approves Amneal Pharmaceuticals’ Alzheimer’s and oncology treatments

The US Food and Drug Administration (FDA) has granted approval for Amneal Pharmaceuticals’ three medications, memantine/donepezil extended-release capsules and everolimus tablets for oral suspension, with tentative approval for rifaximin oral tablets.

FDA grants fast track status to Nacuity’s NPI-001 for retinitis pigmentosa

The US Food and Drug Administration (FDA) has granted fast track designation to Nacuity Pharmaceuticals’ NPI-001 (N-acetylcysteine amide) tablets for treating individuals with retinitis pigmentosa (RP).

Health Canada authorises Roche’s Vabysmo for certain eye conditions

Health Canada has granted authorisation to Roche Canada's Vabysmo (faricimab injection) to be used in a 6.0 mg single-use pre-filled syringe (PFS) for treating diabetic macular oedema, wet or neovascular, age-related macular degeneration (AMD), and macular oedema secondary to retinal vein occlusion (RVO).

FDA clears Axcynsis’ AT03-65 IND for CLDN6-positive solid tumours

The US Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) of Axcynsis Therapeutics’ antibody-drug conjugate (ADC), AT03-65, targeting CLDN6-positive solid tumours.

JW Therapeutics’ Carteyva receives breakthrough therapy status for r/r LBCL

JW Therapeutics has received breakthrough therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) for Carteyva (relmacabtagene autoleucel injection) to treat relapsed or refractory large B-cell lymphoma (r/r LBCL).