Approvals

US FDA grants orphan drug status to Palatin’s obesity treatment PL7737

Palatin Technologies has secured orphan drug designation from the US Food and Drug Administration (FDA) for PL7737, an oral treatment targeting leptin receptor (LEPR) deficiency obesity.

FDA approves Novartis’ Fabhalta for C3 glomerulopathy treatment

The US Food and Drug Administration (FDA) has granted approval for Novartis’ Fabhalta (iptacopan), intended to minimise proteinuria in the adult population with C3 glomerulopathy (C3G).

Health Canada approves Arcutis’ roflumilast cream 0.15% for atopic dermatitis

Health Canada has granted approval for Arcutis’ topical formulation Zoryve (roflumilast cream 0.15%) for mild to moderate atopic dermatitis (AD) treatment in adults and paediatrics aged six years and above.

FDA grants orphan drug status for Korro Bio’s AATD therapy

The US Food and Drug Administration (FDA) has granted orphan drug designation for Korro Bio’s KRRO-110 to treat alpha-1 antitrypsin deficiency (AATD).

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.