News - Page 3

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

CSL, which earlier this year shelved plans to put its CSL Seqirus vaccine division up for sale, has opened the doors to a new $1 billion cell-based flu shot and antivenom facility

Mark Cuban, the co-founder of online pharmacy Cost Plus Drugs, says his company would produce generic drugs in the U.S. if the FDA eliminated approval fees.

The Buckland Group launched Quvara Medical as the newest CDMO to debut this year after buying a former Becton Dickinson manufacturing site in the U.K. for an undisclosed price.

Excelsior Sciences, which spun out of investment firm Deerfield Management, has roped in $95 million to scale its chemical synthesis “smart bloccs” platform, invest in its internal pipeline and forge partnerships across