Approvals
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.
Although January was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.
The approval was based on two randomized open-label clinical trials that evaluated the combination of empagliflozin, linagliptin and metformin and their individual components in healthy adults.
Dificid is a macrolide antibiotic that was previously approved for CDAD in adults.
Robert Bazemore, president and chief executive officer of Epizyme, called the accelerated approval of Tezverik “a landmark event” for people with epithelioid sarcoma, a soft-tissue cancer.
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