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In a bid to better deploy its boots-on-the-ground resources, the FDA is rolling out a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to complement its traditional site

Last month, when Optimi Health kicked off an initial public offering of 2.5 million shares, the timing couldn’t have been better for the Vancouver-based manufacturer of psychedelic drugs. With President Donald Trump recently signing

With commitments to invest more than $50 billion in building up its U.S. manufacturing presence, Eli Lilly has earmarked an additional $4.5 billion to upgrade two of its three planned production facilities

Novartis is continuing its multiyear overhaul with new plans to shutter its production facility in Wehr, Germany, by 2028. The move, announced Tuesday, will eliminate about 220 jobs, according to Novartis.

The German vaccine maker plans to wind down operations at a handful of its sites in Germany plus one in Singapore, putting as many as 1,860 jobs on the chopping block.

Though largely operating in the background until recently, Prolific Machines’ optogenetic approach to biomanufacturing is set to make waves thanks to the achievement of an impressive milestone in monoclonal antibody manufacturing.

The company chalks up a financial impact of about 150 billion Korean won ($102 million) from “preemptive production adjustments” made to mitigate potential manufacturing impacts, a spokesperson said.

After topping up its long-running operations in Puerto Rico last year, Amgen is infusing $300 million more into the U.S. territory.

The company looks to achieve an “amicable resolution as soon as possible” and is focused on minimizing disruption to its operations, a spokesperson said in an emailed statement.

Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when replying to the