Sanofi has received a priority review from the US Food and Drug Administration (FDA) for its new drug application (NDA) for venglustat, an oral glucosylceramide synthase inhibitor (GCSi) intended for the treatment of type 3 Gaucher disease (GD3).
Autobahn Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for elunetirom, its lead central nervous system (CNS)-directed thyroid hormone receptor agonist.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Pierre Fabre Laboratories’ Braftovi (encorafenib) for the treatment of metastatic colorectal cancer (mCRC) with BRAFV600E mutations.
Boehringer Ingelheim has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
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 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 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.
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 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.
Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for Sotyktu (deucravacitinib) to treat active psoriatic arthritis (PsA).
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