Regulation - Approvals

FDA approves Enhertu for two HER2-positive early breast cancer indications

The US Food and Drug Administration (FDA) has approved Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) for two new indications in human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Kyowa Kirin secures FDA approval for Crysvita dosing update

Kyowa Kirin has received approval from the US Food and Drug Administration (FDA) for a dosing update to the prescribing information for Crysvita (burosumab-twza), introducing a new option for adults with X-linked hypophosphataemia (XLH).

Pfizer receives EC approval for Hympavzi to treat haemophilia

Pfizer has received the European Commission’s (EC) marketing authorisation for expanding the approved Hympavzi (marstacimab) indication to treat haemophilia A or B with inhibitors in patients aged 12 years and above.

UAE approves AstraZeneca’s Baxfendy for hypertension

AstraZeneca has received approval from the Emirates Drug Establishment (EDE) in the UAE for Baxfendy, a medicine using the active ingredient baxdrostat, for uncontrolled hypertension.

Partner Therapeutics secures FDA approval for Bizengri

Partner Therapeutics has received the US Food and Drug Administration (FDA) approval for Bizengri (zenocutuzumab-zbco) to treat adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring a neuregulin 1 (NRG1) gene fusion and who have progressed on or after prior systemic therapy.

BMS’ Sotyktu secures EC approval for psoriatic arthritis

Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for Sotyktu (deucravacitinib) to treat active psoriatic arthritis (PsA).

Lannett, Lanexa Biologics and Sunshine Lake secure FDA approval for Langlara

Sunshine Lake Pharma, Lannett and its wholly owned subsidiary Lanexa Biologics have received approval from the US Food and Drug Administration (FDA) for Langlara (insulin glargine-aldy), an interchangeable biosimilar of Lantus (insulin glargine).

Arrowhead’s Redemplo secures Australian TGA approval for FCS therapy

Arrowhead Pharmaceuticals has received approval from the Australian Therapeutic Goods Administration (TGA) for Redemplo (plozasiran) to treat familial chylomicronemia syndrome (FCS).

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.