Celltrion says its biosimilars for Herceptin and Rituxan could be approved this year after it made plant improvements to resolve and FDA warning letter.
Sarepta Therapeutics and CDMO Brammer Bio have inked a deal for the production of its microdystrophin Duchenne muscular dystrophy therapy and future gene…
FDA inspectors found that AbbVie didn’t include historical death complaints for the same lot in its search system for its all-too-important drug Humira.
