regulatory

News

FDA launches pilot programme to boost US manufacturing

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

News

UCB closes on first EU OK for TK2d therapy

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

News

Bottle of Tavneos with two pills in front of it

EMA looks into 'data integrity' issue with Amgen's Tavneos

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

FDA starts review of Summit's VEGFxPD-1 bispecific

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

ADHD in wooden letters surrounded by white pills

Otsuka preps for July decision on centanafadine for ADHD

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.

Digital

Digital mental health technologies and the changing face of ...

Digital Mental Health Technologies, from apps and online platforms to AI-powered tools, are fast being seen as essential to help close treatment gaps.

FDA launches pilot programme to boost US manufacturing

UCB closes on first EU OK for TK2d therapy

EMA looks into 'data integrity' issue with Amgen's Tavneos

FDA starts review of Summit's VEGFxPD-1 bispecific

Otsuka preps for July decision on centanafadine for ADHD

Digital mental health technologies and the changing face of ...

Repligen builds in cell therapy with $1.5bn BioLife takeover

Discover a new era of healthcare panel engagement: Grounded ...

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