The FDA has announced that it has approved Rezdiffra (resmetirom) for the treatment of adult patients with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver scarring (fibrosis), for use alongside diet and exercise.

Spero Therapeutics has announced that it has gained FDA clearance for the investigational new drug (IND) application to assess SPR206 in a phase 2 clinical study.

Johnson & Johnson (J&J) has announced that the FDA has approved Opsynvi (macitentan and tadalafil) for the chronic treatment of adults with pulmonary arterial hypertension (PAH).

AstraZeneca has announced that the FDA has approved Ultomiris (ravulizumab-cwvs) as the first and only long-acting c5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (aqp4) antibody-positive (ab+) neuromyelitis optica spectrum disorder (nmosd).

AstraZeneca has announced that the FDA has approved Tagrisso for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

GSK has announced that the FDA has granted fast track designation for bepirovirsen, an investigational antisense oligonucleotide for the treatment of chronic hepatitis b.

Johnson & Johnson has announced that the FDA has granted breakthrough therapy designation for nipocalimab for the treatment of alloimmunised pregnant individuals at high risk of severe haemolytic disease of the foetus and newborn.

Argenx has announced that the FDA has accepted a supplemental biologics license application (sBLA) for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for priority review.

Ipsen has announced that the FDA has approved the supplemental new drug application for Onivyde (irinotecan liposome injection) plus oxaliplatin, fluorouracil and ;eucovorin (Nalirifox) as a first-line treatment for adult patients with metastatic pancreatic adenocarcinoma (mpdac).

Merck has announced that the FDA has approved Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of figo (international federation of gynecology and obstetrics) 2014 stage iii-iva cervical cancer.

Johnson & Johnson (J&J) has announced that the FDA has approved a supplemental new drug application for Balversa (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 genetic alterations whose disease has progressed on or after one prior treatment.

AstraZeneca and Ionis have announced that the FDA has approved Wainua (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (haattr-pn or attrv-pn) in adult patients.