regulatory

News

The FDA has turned down Pharming's bid to broaden the label of Joenja for rare immunodeficiency disorder APDS so it can be used in younger patients.

News

The FDA has started accepting requests to participate in its PreCheck pilot programme, promising rapid reviews of new manufacturing facilities.

News

UCB gets an EU recommendation for the first therapy for thymidine kinase 2 deficiency (TK2d), plus other CHMP decisions.

News

Concerns about efficacy data in the main trial behind the approvals of Amgen and CSL Vifor's Tavneos have triggered a review in the EU.

News

Summit moves ahead in the race to bring a VEGFxPD-(L)1 drug to market, after the FDA started a review of ivonescimab in lung cancer.

News

The FDA has started a priority review of Otsuka's triple-acting drug for ADHD, setting up a decision on the first-in-class drug in July.