In just three months, Phlow and Enveda generated and analyzed nearly 20,000 unique reactions, creating one of the largest high-quality datasets of its kind. The resulting uniform dataset is ...

Operating under the FDA's 503B pathway, the Apex facility will prioritize the production of generic shortage-listed ...

Ardena has completed the process of divesting its active pharmaceutical ingredient (API) site in Södertälje, Sweden, to Nanologica AB.

The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...

Scheduled for August 2025 completion, the initial $2-billion phase included construction of a 1-million-sq-ft complex with two drug substance manufacturing buildings, each containing four 20,000-liter ...

By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...

Fujifilm Biotechnologies will open a new biologics manufacturing plant in the U.S. this fall, with Regeneron and Johnson & Johnson as the initial customers. The Holly Springs, North Carolina, site is ...

USP is developing digital reference standards to integrate into modern digital environments, enhancing regulatory confidence ...

VILNIUS, LT / ACCESS Newswire / July 29, 2025 / Diorasis Therapeutics (“DTx”), a preclinical-stage biotechnology company developing gene therapies for ophthalmic diseases, has entered into a strategic ...

President Donald Trump signed an executive order to incentivize drug manufacturing in the U.S. The order comes ahead of Trump's planned tariffs on pharmaceuticals imported into the U.S. U.S.