regulatory approval

News

Novartis gets FDA nod for second of three IgAN drugs

Novartis has claimed accelerated approval in the US for Vanrafia, one of a trio of drugs it hopes will revolutionise the treatment of IgA nephropathy.

News

UK first to approve Rotop's prostate cancer imaging agent

The UK has given a world-first approval to Rotop's RoTecPSMA, a new imaging agent for detecting lesions in men with prostate cancer.

News

FDA clears first treatment for Prader-Willi syndrome

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

News

GSK ends decades-long hiatus in oral antibiotics for UTIs

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

News

Fabhalta is first FDA-approved therapy for rare disease C3G

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

News

J&J adds to IL-23 options in Crohn's after FDA approval

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.

Novartis gets FDA nod for second of three IgAN drugs

UK first to approve Rotop's prostate cancer imaging agent

FDA clears first treatment for Prader-Willi syndrome

GSK ends decades-long hiatus in oral antibiotics for UTIs

Fabhalta is first FDA-approved therapy for rare disease C3G

J&J adds to IL-23 options in Crohn's after FDA approval

Lilly bags FDA okay for Wegovy pill rival orforglipron

Using AI-driven synthetic personas to take your insights fur...

regulatory approval

Editor's Picks