The FDA was supposed to be delivering its verdict on Axsome Therapeutics' depression therapy AXS-05 in less than a fortnight – but instead has delivered the company a letter outlining defic
The FDA has demanded another clinical trial of FibroGen and AstraZeneca's roxadustat for anaemia caused by chronic kidney disease (CKD) before it will consider approval, setting up a length
Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder.
The FDA's approval of Biogen's Aduhelm for Alzheimer's disease has emboldened Eli Lilly to move forward plans to file its own candidate donanemab later this year, although it acknowledges i
Bristol-Myers Squibb's HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed
The FDA has relaxed a clinical hold on clinical trials of Novartis' intrathecal formulation of spinal muscular atrophy (SMA) gene therapy Zolgensma, allowing a new phase 3 trial to get unde
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.