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The triple combination therapy plus ivacaftor was previously approved for this indication in the U.S. and Australia, where Kaftrio is marketed as Trikafta. Read More
The experimental gene therapy has also secured Fast-Track, Orphan Drug, Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations from the FDA. Read More
The FDA is reviewing significantly higher numbers of generic drugs under its Competitive Generic Therapy (CGT) pathway, the latest quarterly report on the agency’s GDUFA II performance reveals. Read More
The FDA has granted accelerated approval to GlaxoSmithKline’s monoclonal antibody Jemperli (dostarlimab) for treating women with recurrent or advanced endometrial cancer. Read More
The FDA gave the drug a breakthrough status based on results of a phase 2 study showing the drug plus chemotherapy significantly improved survival for patients. Read More
The FDA’s latest quarterly snapshot of the agency’s GDUFA II performance shows fewer abbreviated new drug applications (ANDAs) under review than for the same time last year and that the agency is taking much longer to issue tentative approvals. Read More
As global criminals step up efforts to exploit the pandemic, Pfizer is combating the sale of counterfeit versions of its COVID-19 vaccines in Mexico and Poland. Read More