Biocon has seen its earnings hit by FDA and EU regulatory issues at its Indian plant that makes the biosimilars it and partner Mylan have developed.
India-based API maker Vital Laboratories was slapped with a warning letter from the FDA over manufacturing and records issues at its Plant II located in Vapi,…
Three major regulatory bodies – FDA, EMA and Health Canada – changed their guidelines to drug naming. How could these changes impact drug launch timelines?
China's FDA approved a domestically developed Ebola vaccine based on a different virus type from GSK's and Merck's shots.
No currently available vaccines against typhoid are meant for children younger than 2, but a new WHO endorsement could change that.
An Akorn sterile drug plant is in hot water with the FDA again, but it may be a problem for Fresenius Kabi, which is buying the generics manufacturer.
A report by the European Medicines Agency lays out the reason why German regulators pulled the GMP certificate from a Dr. Reddy's plant in India.
Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.
The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert.
AstraZeneca rolled out positive results for a LAMA/LABA that could help the company gain a respiratory foothold in Asia.
Gilead Sciences has received approval for Sovaldi from China's FDA, gaining a foothold in the world's largest hepatitis C market.