regulatory approval

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Patients in the US with Sanfilippo syndrome type A have their first FDA-approved therapy, Ultragenyx Pharma's $3.9m one-shot gene therapy Fayuvi.

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Bayer's fast-growing Kerendia has had its label extended in the US to include chronic kidney disease associated with type 1 diabetes.

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Curium's copycat version of Novartis GEP-NET therapy Lutathera, Bexlutry, is the first radioligand equivalent (RLE) to be approved by the FDA.

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Scholar Rock has won its first product approval, on its second attempt, as the FDA gives a green light to its spinal muscular atrophy drug Isembyld.

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Hengrui's oral TPO agonist, hetrombopag, is the first in the class to be approved for thrombocytopenia caused by chemotherapy for solid tumours.

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Bayer chases after Boehringer with an FDA approval for oral HER2 inhibitor Hyrnuo in previously untreated HER2+ lung cancer.