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Contract manufacturing powerhouse Lonza is growing in more ways than one. The Swiss company revealed this week that it is expanding its capacity to manufacture antibody-drug conjugates—and that it has increased the

On a quest to bolster its life-sci contracting bona fides, self-described “multifaceted manufacturer” Kimball Electronics is going down the path of M&A.

Eli Lilly, Regeneron and Fujifilm are among the seven companies that have been selected to participate in the FDA’s PreCheck Pilot Program, designed to strengthen drug manufacturing and supply chain resilience in

Unicycive is optimistic the third-party manufacturing facility can meet FDA standards to support an approval, CEO Shalabh Gupta, M.D., said in a statement.

Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA.

The agency spotted seven observations at Dr. Reddy’s Bachupally, Hyderabad, biologics plant following a mid-June inspection.

Jubilant HollisterStier, a CDMO unit of India’s Jubilant Pharmova, earned an FDA warning letter after inspectors found its Montreal production plant lacked appropriate quality control systems.

AdvanCell, a clinical-stage radiopharmaceutical outfit, inked a lease near Boston to produce its prostate cancer candidate and set roots down for its U.S. headquarters.

Most of those two weeks is not science. It is finding and assembling the data, which is also where most of the AI sold to pharma quietly stalls.

With interest in automated cell therapy production beginning to build from about 2016 onward, some 23 companies working in the field have now raised a collective $1.1 billion across 34 rounds through