Travere Therapeutics has received the US Food and Drug Administration (FDA) full approval for Filspari (sparsentan) to reduce proteinuria in adult and paediatric patients aged eight years and above with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
Merck & Co (MSD) and Daiichi Sankyo have received priority review from the US Food and Drug Administration (FDA) for ifinatamab deruxtecan’s biologics licence application (BLA) to treat extensive-stage small cell lung cancer (ES-SCLC).
Merck (MSD) has received the European Commission (EC) approval for Keytruda (pembrolizumab) along with paclitaxel, with or without bevacizumab, as a treatment for programmed death-ligand 1 (PD-L1)-positive ovarian cancer.
Telomir Pharmaceuticals has submitted an investigational new drug application to the US Food and Drug Administration for Telomir-1 (Telomir-Zn), its lead candidate targeting advanced and metastatic triple-negative breast cancer (TNBC).
Teva Pharmaceutical has announced the US Food and Drug Administration (FDA) approval for Ponlimsi (denosumab-adet) as a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair (omalizumab) by both the agency and the European Medicines Agency (EMA).
Novo Nordisk has secured the US Food and Drug Administration (FDA) approval for Awiqli (insulin icodec-abae) injection 700 units/mL, a basal insulin for adults with type 2 diabetes (T2D).
Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has received approvals for two new indications in classical Hodgkin Lymphoma (cHL) from the US Food and Drug Administration (FDA) and the European Commission (EC), expanding its use for both paediatric and adult patients.
The US Food and Drug Administration (FDA) has accepted for review Sun Pharmaceutical’s supplemental biologics licence application (sBLA) submitted for Ilumya (tildrakizumab-asmn) to treat adults with active psoriatic arthritis.
Novartis has received the US Food and Drug Administration (FDA) approval for Cosentyx (secukinumab) to treat paediatric patients aged 12 years and above with moderate to severe hidradenitis suppurativa (HS).
The US Food and Drug Administration (FDA) has granted its approval for the expanded use of GSK’s Wellcovorin (leucovorin calcium) tablets to treat cerebral folate deficiency (CFD) in patients with a confirmed variant in the folate receptor one (FOLR1) gene.
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