Approvals
The U.S. Food and Drug Administration approved Shionogi’s Fetroja as a treatment for adult patients with complicated urinary tract infections caused by a number of Gram-negative microorganisms.
The approval marks the first approved treatment in the United States for this condition.
Ziextenzo (pegfilgrastim) is a long-acting version of filgrastim and is indicated to decrease the incidence of infection in cancer patients.
In clinical trials, Talicia demonstrated 90% efficacy in the eradication of H. pylori in studies and is the only rifabutin-based therapy on the market.
The approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway.
This morning’s approval from the U.S. Food and Drug Administration marks the 11th therapeutic indication for Botox, a product tent pole for Ireland-based Allergan.
GlaxoSmithKline’s PARP inhibitor Zejula has been approved for wider use in some cancers.
The U.S. Food and Drug Administration approved a new cystic fibrosis medication that is expected to provide treatment for 90% of patients with this debilitating and life-shortening condition.
The approval is based on the Phase III UNIFI study that showed that after eight weeks of taking a single intravenous dose of Stelara, patients saw “clinical remission in a significantly greater proportion of UC patients.”
Thanks to a new regulatory win, AstraZeneca’s Farxiga can now be used to reduce the risk of hospitalization for heart failure in type 2 diabetes patients with cardiovascular disease and with certain risk factors.
PRESS RELEASES