FDA
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.
FEATURED STORIES
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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Seqirus snagged approval for Fluad Quadrivalent, the first-and-only quadrivalent adjuvanted influenza vaccine developed to help protect adults 65 years and older against seasonal influenza.
H. Lundbeck A/S is making a statement with its newly approved treatment for migraine, the first intravenous medication approved for the preventative treatment of migraine.
The company is planning for its drug for cholesterol lowering medications to hit the streets by the end of March. It will provide a new option to all the patients.
The approval marks the first once-per-day 24-hour, intravenous COX-2 preferential NSAID, the company said.
Here’s a look at the two drugs that had dates this week but were approved early and are now on the market.
The U.S. Food and Drug Administration has a busy week planned for drug review. Here’s a look at this week’s schedule.
A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration’s priority review program.
The FDA gave tentative approval for the drug in 2018, but the holdup was over patent issues.
Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.
For the millions of people suffering from an allergy to peanuts, there is a new, first-of-its-kind treatment available. On Friday, the U.S. Food and Drug Administration approved Aimmune Therapeutics’ oral immunotherapy AR101.