Galapagos to decide on fate of cell therapy business ‘within weeks’

The company has received a “limited number” of non-binding proposals, mostly from groups of financial investors, for a business that was once its primary focus.

Takeda, in reversal, abandons cell therapy research

The Japanese pharmaceutical company, which had made cell therapy a priority a few years ago, aims to partner its work while prioritizing investments elsewhere.

Inside the world of RNA therapies

As shutdown begins, FDA to stop accepting new drug submissions

The funding lapse triggered by the U.S. government shutdown is the latest test for an agency that’s already dealt with significant layoffs and leadership upheaval this year.

5 FDA decisions to watch in the fourth quarter of 2025

Against the backdrop of a government shutdown, the agency has a series of critical decisions ahead, among them verdicts on new therapies from Novo Nordisk and Biohaven.

Crinetics drug to challenge pharma ‘Goliaths’; FDA, ARPA move to speed gene therapies

Crinetics’ acromegaly treatment will go up against several entrenched medicines. Elsewhere, Bristol Myers moved to sell Sotyktu online at a discount and regulators rejected a new version of Biogen’s Spinraza.

Scientists use cloning technology to swap DNA in human eggs

Kennedy expands role in FDA decision-making

Opus sets sights on FDA talks after posting gene therapy data