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FDA reviewers will revisit Merck’s anesthesia drug sugammadex this week in its fourth review attempt, taking on safety concerns that originally tripped up the candidate in 2008. Read More
On Thursday, the FDA approved Gilead’s Genvoya, a once-daily complete regimen for adults and pediatric patients 12 years of age and older with HIV-1 infection. Read More
While there is no set timeframe for the release of FDA’s final quality metrics guidance, the agency has plans to recruit volunteers to conduct a “dry run” in the spring to test the collection and sending of data to the agency. Read More
French drugmaker Sanofi is looking to future-proof its diabetes franchise by in-licensing rights to a trio of next-generation diabetes medicines from South Korea’s Hanmi in a deal worth up to $4.2 billion. Read More
The FDA is now recommending a traditional approval pathway for development of antiretroviral drugs for HIV-1 infection, a major shift from the condensed process allowed since the epidemic was at its peak. Read More
A British charity is pledging roughly $154 million over the next five years toward research into treatments and diagnostics to improve cancer survival. Read More
The moment dietary supplement manufacturers start making specific curative claims, supplements are seen as drugs in the eyes of the FDA and require an IND, says a new guidance document. Read More
Drugmakers want the FDA to provide more details on how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate. Read More