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In a phase 3 study, Benlysta plus standard therapy improved kidney response rates and prevented worsening of kidney functions vs. standard therapy alone. Read More
The FDA has issued a complete response letter (CRL) to LEO Pharma, requesting additional information regarding a device component for the Danish drugmaker’s moderate-to-severe atopic dermatitis candidate tralokinumab. Read More
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