February 12th 2025
Approval makes Gomekli the first treatment to be approved for both adults and pediatric patients for neurofibromatosis type 1, a genetic disorder that causes noncancerous tumors to grow on nerves throughout the body.
Further Guidance on Biosimilars Needed from FDA
March 9th 2015The approval of the first biosimilar for market in the U.S. highlights the importance of further clarification from FDA on key policies related to the development and prescribing of highly similar biologics for patients, writes Jill Wechsler.
Obama's Mixed Message for Biopharma R&D
February 3rd 2015President Obama has unveiled his $215m “Precision Medicine Initiative” to support the future biomedical research, while calling for a reduction in exclusivity on brand biologics from 12 to 7 years and a curb on "evergreen” patents on certain biologics. Jill Wechsler reports.