China plans to merge CFDA into a massive market-supervision agency, while maintaining drug regulation as a separate bureau under it.
TaiMed Biologics' new HIV med, just approved by the FDA, will be produced by WuXi Biologics in the first Chinese biologics plant approved by the FDA.
Seven years in the market, Samsung BioLogics is already starting to stand out among the CDMO companies. Samsung BioLogics started as a CMO and repositioned…
The FDA issued a warning letter to Chinese OTC drugmaker Zhejiang Ludao Technology, citing data integrity and product testing issues.
Trogarzo (ibalizumab-uiyk) is the first HIV therapy with a novel mechanism of action in more than 10 years.
Pfizer’s Hospira has issued a voluntary recall of three lots of the painkiller hydromorphone, an injectable, due to an apparent manufacturing issue that could…
Regulatory problems are piling up for the sterile manufacturing operations of India’s Aurobindo, which has had another plant cited by the FDA.
Shionogi's Roche-partnered Xofluza, a one-time, single-dose regimen, probably won't win U.S. approval till next winter.
After two refusals from Sanofi to provide a refund for the Dengvaxia program, officials in the Philippines say they are getting ready to sue.
After a year of remediation, an Indian drugmaker has worked its way out from under an FDA warning letter issued for its sterile injectables operation.
The impact of an FDA warning letter issued last month for a Celltrion plant in South Korea has broadened to Teva Pharmaceuticals.