regulatory approval

News

Merck unit SpringWorks has claimed EU approval for Ogsiveo, becoming the first approved therapy for desmoid tumours in Europe.

News

Tonix Pharma is preparing to launch a new therapy for fibromyalgia that analysts predict could make hundreds of millions of dollars in annual sales.

News

Under pressure from rivals in the GLP-1 space, Novo Nordisk has been given a leg-up with a first-in-class approval for Wegovy in liver disease MASH.

News

Precigen has won approval in the US for a first-in-class immunotherapy for recurrent respiratory papillomatosis, Papzimeos, its first product.

News

A newly approved AI from Artera can guide treatment and predict prognosis in people diagnosed with localised prostate cancer.

News

Insmed has claimed the distinction of getting the first FDA approval for a treatment for chronic lung disease non-cystic fibrosis bronchiectasis.