Regulation

Axsome receives FDA approval for Auvelity to treat Alzheimer’s agitation

Axsome Therapeutics has received the US Food and Drug Administration (FDA) approval for Auvelity (dextromethorphan HBr and bupropion HCl) to treat agitation associated with dementia due to Alzheimer’s.

FDA approves AstraZeneca’s Saphnelo for SLE

AstraZeneca has received approval from the US Food and Drug Administration (FDA) for the subcutaneous self-administration of Saphnelo (anifrolumab-fnia) using the Saphnelo Pen autoinjector for systemic lupus erythematosus (SLE).

Novartis secures pair of regulatory wins for skin disease and malaria treatments

Novartis has netted a pair of regulatory wins, winning European approval for an oral therapy in chronic spontaneous urticaria (CSU) and, separately, receiving World Health Organization (WHO) prequalification for its antimalarial medication.

Travere Therapeutics gains FDA approval for sparsentan in FSGS

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.

MSD, Daiichi Sankyo’s ifinatamab deruxtecan receives FDA priority

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).

MSD secures EC clearance for Keytruda combination therapy for ovarian cancer

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 seeks FDA approval for Telomir-1 to treat breast 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 receives FDA approval for Prolia biosimilar

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 receives FDA approval for basal insulin Awiqli

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).