JAK inhibitor, now first oral UC medication in US, is approved for both 5mg and 10mg, but label currently discourages 10mg after 16 weeks.
Postmarketing trials may help alleviate the US FDA's concerns about the long-term use of a high dose of Pfizer Inc.'s Xeljanz (tofacitinib) in ulcerative colitis (UC).
FDA's May 30 approval of the product in UC made the JAK inhibitor the first oral therapy marketed for the...
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
