Topic: complete response letter
Merck's HPV shot Gardasil won approval in China, Lupin's Q4 sales in North America fell 13%, and China’s CANbridge gained a $25M series B.
The manufacturing problems at Sun Pharma’s key Halol, India, plant have again stymied approval of a new drug from Sun's novel drug development group, SPARC.
Investors were in the mood for good news from Eli Lilly—and they got a bit of it in its first-quarter earnings report, even as pipeline worries cast a cloud over the numbers.
The FDA posted a document outlining the issues that have undermined AstraZeneca's efforts to win approval for ZS-9.
Pfizer's Xeljanz is an obvious beneficiary of Eli Lilly's surprise Olumiant (baricitinib) rejection at the FDA. But AbbVie and Gilead could gain, too.
Eli Lilly and partner Incyte have received a complete response letter for their highly anticipated rheumatoid arthritis drug baricitinib.
With rivals coming up with heart-helping outcomes data, Merck wants its label to show its Januvia doesn’t hurt heart health. U.S. regulators say not so fast.
Valeant Pharmaceuticals International said today that it has gotten a new PDUFA date for its eye drug candidate latanoprostene bunod, which the FDA sidelined last year because of manufacturing concerns.
Having a potential blockbuster sidelined because of manufacturing issues is bad enough, but AstraZeneca has now had that experience twice.