FDA
The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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It is the first BeiGene-discovered drug to be approved.
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.”