regulatory approval

News

Soleno Therapeutics' Vykat XR has become the first FDA-approved treatment for excessive eating in rare disorder Prader-Willi syndrome.

News

The FDA has approved GSK's Blujepa, the first new-mechanism oral antibiotic for uncomplicated UTIs in nearly 30 years, after a priority review.

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Novartis' oral complement inhibitor Fabhalta has become the first approved treatment for rare kidney disease C3G as it chases a $3bn sales target.

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J&J's Tremfya gets a much-anticipated FDA approval for Crohn's disease, which the company thinks will be key to a renewed phase of sales growth.

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Alnylam has claimed FDA approval for Amvuttra in ATTR cardiomyopathy, allowing it to compete with rival therapies from Pfizer and BridgeBio.

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Kelun-Biotech wins first global regulatory approval - in China - for a TROP2-directed antibody-drug conjugate (ADC) in lung cancer.