Pfizer’s blockbuster rheumatoid arthritis drug Xeljanz has been a strong performer for the company, bringing in $1.77 billion in revenue last year, but now the company has indicated it intends to make a change in a post-marketing study due to safety concerns.
After the U.S. Food and Drug Administration took a hard line on the use of real-world evidence in clinical trials, industry leaders are beginning to back the idea, but with some minor changes.
Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. Food and Drug Administration placed profits before patient safety.
Bayer AG’s Essure birth control implant should carry the strongest safety warning label, U.S. regulators said on Monday, following thousands of complaints about the device. The U.S. Food and Drug Administration also asked the German drugmaker to conduct a post-market study of the device. Essure, acquired by Bayer in 2013, has been the target of […]
Many high-risk therapeutic devices get Food and Drug Administration (FDA) approval with only one study proving their safety and efficacy before going to market. Studies of how the devices work once they are on the market are also few and far between, according to a new study that looked at all 28 high-risk devices approved […]