Telix Pharmaceuticals Limited

The US Food and Drug Administration’s missed user fee goal date for Stealth BioTherapeutics ’ Barth syndrome drug elamipretide may be another signal of drug regulatory work slowed by recent layoffs a

“Pipeline in a pill”-style drug development will be on display in April, when more than half of the user fee goal dates are for new indications on sometimes sprawling labels, as well as one novel biol

ITM Isotope Technologies Munich is preparing the complex logistics and manufacturing it will need for commercial launch of ITM-11 (non-carrier-added 177 Lu-edotreotide), its radiopharmaceutical candid

The disruption of existing markets is a dominant ambition of the nearly 20 applications expecting US Food and Drug Administration action in March. The Pink Sheet ’s US FDA Performance Tracker shows