Regulation - Approvals

Roche’s giredestrant secures FDA priority review for breast cancer

The US Food and Drug Administration (FDA) has accepted priority review of the new drug application (NDA) for Roche’s investigational oral selective oestrogen receptor degrader (SERD), giredestrant, for breast cancer.

FDA approves AstraZeneca’s Imfinzi-BCG combination for NMIBC therapy

AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).

FDA grants priority review for Sanofi’s venglustat NDA

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’s elunetirom receives FDA fast track designation to treat adjunctive bipolar

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.

Pierre Fabre’s Braftovi gains CHMP positive opinion for mCRC

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.

Japan’s MHLW approves Boehringer’s Jascayd for IPF and PPF

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).

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.