A clutch of swift FDA decisions boosted average US drug approval times in 2019, helping biopharma to deliver another bumper crop of new medicines.
The unexpected approval of Vyondys 53 followed an FDA power struggle, and turned on a vague commitment from Sarepta, it has emerged.
The second half of 2019 saw half as many innovative medical devices approved as the first.
In the battle between two Kit/PDGFRα kinase inhibitors first blood goes to Blueprint’s avapritinib.
On the corporate front Astellas continued to buy, while Qiagen decided that it was not, after all, up for sale.
Enhertu gets an early thumbs up from the FDA – now decisions are due for Epizyme’s tazemetostat and Novo Nordisk's Rybelsus and Ozempic.
The German start-up must navigate the hazards that have felled other surgical robot developers while simultaneously dealing with a more crowded market.
Rather than nipping at Adakveo’s heels, Global Blood Therapeutics’ newly approved sickle cell drug Oxbryta might end up floundering in the Novartis product’s wake.
Alnylam unveils a novel pricing strategy for its second RNAi launch, which was greenlit by the US regulator with notable speed.