News is a concise, evidence-aware briefing on what matters in healthcare—new trials, guideline changes, drug approvals, device safety, and health-policy shifts.
Pharma giant AstraZeneca extended its supply deal with Michigan-based medical radioisotope producer Niowave by 10 years, teeing up the delivery of Actinium-225 that has shown promise as a component in targeted cancer
Incog BioPharma, a sterile injectables CDMO, plans to shell out about $200 million to boost production capacity at its Fishers, Indiana, manufacturing site.
Samsung Bio’s U.S. subsidiary will pay $280 million to acquire GSK’s Human Genome Sciences and its two pharmaceutical manufacturing plants at a campus in Rockville, Maryland. The site, which will mark Samsung
The Elevidys-related manufacturing shortfalls were described in one of two Form 483s tied to FDA inspections that came before Catalent’s layoff spree at its Maryland gene therapy manufacturing business.
After seeing some of its financial momentum slow this year, Bicycle Therapeutics got a push from two U.K. nuclear agencies in the form of up to 440 tons of reprocessed uranium the
Novo Nordisk, which has stumbled through a bit of a manufacturing hangover at a former Catalent production site it picked up last year, was hit with a warning letter from the FDA.
About a year and a half after telegraphing plans to shift its headquarters from New Jersey to Philadelphia, CDMO Adare Pharma Solutions appears to be turning out the lights at another facility
Roughly half a year after introducing the new regulatory pathway, the FDA has greenlit the first drug under its ultra-speedy—and controversial—Commissioner’s National Priority Voucher pilot review program. The inaugural approval under the
Bora and Corealis are joining forces to create a new end-to-end CDMO offering for oral solid dose drug development and production. The strategic alliance will be designed to simplify the drug development