With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.
Tag Archive for: regulatory approval
The FDA clearance, announced late on Thursday by the company, makes the vaccine, called ACAM2000, the second approved shot against mpox in the United States after Bavarian Nordic’s (BAVA.CO) Jynneos.
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
Imfinzi’s perioperative approval comes after both the FDA’s staffers and a panel of external experts expressed concerns about overtreatment when using the PD-L1 blocker both before and after surgery.
Nearly two weeks ahead of its target action date, the regulator on Wednesday has signed off on Incyte and Syndax’s Niktimvo for the third-line treatment of graft-versus-host disease.
The regulator’s approval of Livdelzi for primary biliary cholangitis under the accelerated pathway is a boost to Gilead Sciences’ liver disease business. Analysts expect the drug to reach more than $1 billion in sales.
The approval potentially gives emergency medical technicians and combat medics a tool to prevent death from blood loss.
The Swiss company’s monoclonal antibody Nemluvio is also undergoing regulatory review for atopic dermatitis, which is a potentially larger market for the first-in-class IL-31 blocker.
Ascendis’s Yorvipath, will become the only approved treatment for the condition, called hypoparathyroidism, in the United States after rival Takeda stops manufacturing its injection, Natpara, at the end of this year due to supply issues.
“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, M.D., Ph.D of FDA’s CDER.