US FDA approves six NMEs in July; Kalvista, PTC, Regeneron rise

Aug. 26, 2025

The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.

BioWorld Asia Analysis and data insight Regulatory FDA NME

Today's news in brief

BioWorld

BioWorld briefs for Dec. 5, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for Dec. 5, 2025.

Epigenetic technology could eliminate misfolded prion proteins

BioWorld Science

The number of deaths caused by prion diseases reaches about 30,000 annually. Only 5 months pass from the diagnosis of seemingly healthy patients to the fatal...

Mesothelin is biomarker, potential target in arthritic bone damage

BioWorld Science

In a recent study published in Cell Reports Medicine, researchers from the Institute of Chinese Materia Medica of the China Academy of Chinese Medical Sciences...

Gene therapies aim for the big goal of edits in vivo

BioWorld Science

The field of gene therapy is experiencing major advances driven by precise editing technologies, such as base and prime editing, and by the design of increasingly...