Approvals
FDA approved Ascendis Pharma’s Skytrofa for children one year and older who have growth failure from inadequate secretion of endogenous growth hormone.
Less than 10 days after the FDA slammed Sesen bladder cancer drug with a CRL, the company has withdrawn its Marketing Application Authorization from the European Union.
The new authorization is expected to be the final reassurance for many of those who had hesitated when the vaccine was approved under emergency use only.
The FDA has approved the use of the injectable drug KORSUVA in treating moderate to severe pruritus in adult patients undergoing hemodialysis for chronic kidney disease.
Many expect the full approval will lead to vaccine mandates, as that was one of the obstacles to it for many organizations.
The U.S. FDA has a busy schedule for the end of August and beginning of September. Let’s take a look.
Makena injection currently remains on the market but is poised to be removed pending the outcome of the meeting. The final decision will be made in the public hearing.
Specifically, the new approval was for adults with dMMR recurrent or advanced solid tumors who have progressed on or after previous treatment and who have no satisfactory alternatives.
The FDA recommended additional clinical and statistical data analyses of Vicineum, as well as issues related to the company’s Chemistry, Manufacturing, and Controls.
This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions.
PRESS RELEASES