We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has gotten approval for its overhaul of CDER and work will begin by the end of the month, Director Janet Woodcock announced Thursday. Read More
Biosimilar groups are pressing federal agencies including the FDA to make “structural” changes to the biosimilar marketplace, claiming that the U.S. is falling far behind Europe on cheaper treatments. Read More
“Innovative trial designs … may be particularly useful in studies of regenerative medicine therapies to treat rare diseases,” the agency said. Read More
A Florida pharmacist convicted for his role in a huge compounding pharmacy fraud scheme was sentenced on Wednesday to 10 years in prison and ordered to pay millions in restitution. Read More
A New York union has filed a class-action lawsuit against AbbVie and seven other drugmakers, accusing them of throwing up a “patent thicket” to keep cheaper rivals to AbbVie’s blockbuster drug Humira off the market. Read More
The FDA has ordered AbbVie to stop recruiting multiple myeloma patients for a Phase III trial of its anti-cancer drug Venclexta/Venclyxto, the company announced Wednesday. Read More