The FDA has nailed another Teva manufacturing facility with a warning letter, this time for an API facility in China.
The FDA’s decision to ban the products of a Chinese API maker has left the World Health Organization in the lurch trying to find another company to supply the…
Today, RA studies are taking longer and require more sites to complete. With so few patients actually participating in clinical trials, what does the industry…
Sanofi Pasteur's dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia.
Another Mylan plant in India has been issued a warning letter.
Samsung Biologics is on track to complete its third manufacturing plant in Songdo, Incheon, this year.
Gilead is planning its first foreign manufacturing facility, Takeda will develop an IBD drug from Finch while cutting 180 workers at Ariad after the buyout.
Takeda has finished enrolling 20,100 children for a massive phase 3 dengue vaccine study.
Gilead is building a manufacturing facility in China, its first outside the U.S.
The FDA has nailed India's Indoco with a warning letter for a sterile and solid dose plant in Goa because of its concerns over an injected drug.
For the second time in six weeks, Dr. Reddy’s has been rebuffed by the FDA for its efforts to deal with problems outlined in a warning letter two years ago.