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Japanese drugmaker Daito Kasei Kogyo was hit with a warning letter by the FDA for having inadequate testing procedures and falsifying certificates of analysis issued to customers from its facility in Bizen, Okayama. Read More
The FDA issued a complete response letter to Aradigm over its Linhaliq (ciprofloxacin liposomal) submission for non-cystic fibrosis bronchiectasis, a severe, rare lung disease frequently associated with chronic lung infections, saying the drug could not be approved in its current form. Read More
In testimony before a House subcommittee Tuesday, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s level of risk. Read More
Few developers of antibiotics for high-priority pathogens have a plan in place to ensure access when development is complete, researchers found. Read More
Commonly prescribed generic drugs in Canada will see a price cut of up to 40 percent in April as part of a new initiative announced Monday by two drug industry groups. Read More