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The decision by Lonza to move cell-therapy work out of a U.S. facility that was hit by an FDA warning letter will cost the plant about 125 jobs.
An Indian drugmaker has halted production of a couple of APIs after FDA inspectors found it was falsifying data at its manufacturing complex near Tamil Nadu,…
Clinical care experts and patient advocacy organizations call attention to why better patient understanding shapes the best integrated approach to orphan drug…
Fresenius’ $4.3 billion buyout of generics maker Akorn is in jeopardy as they investigate allegations that Akorn violated FDA drug development standards.
Jazz Pharmaceuticals has released new vials of Erwinaze, its leukemia drug for children, that came into short supply in 2016.
After years of effort and a couple of reinspections, India’s Sun Pharma has been unable to satisfy the FDA's expectations for its key plant.
Biocon and Mylan have hit another manufacturing snag on their march toward an FDA nod for their copy of Sanofi's blockbuster Lantus.
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.
A recently released FDA document shows that Pfizer's troubled fill-finish plant in Kansas was cited for continuing to repeat mistakes already cited by the…
The FDA has issued a warning letter to a Bayer finished products plant in Germany, where it says poor cleaning led to product cross-contamination.
The impact of an FDA warning letter issued last month for a Celltrion plant in South Korea has broadened to Teva Pharmaceuticals.