ARS Pharma has claimed FDA approval for its epinephrine nasal spray neffy, becoming the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.
The FDA has denied Lykos Therapeutics' marketing application for its post-traumatic stress disorder (PTSD) therapy based on MDMA, also known as ecstasy, in a setback for the emerging psyche
At the second attempt, the FDA has approved Citius Pharmaceuticals' marketing application for Lymphir, a new version of a lymphoma therapy withdrawn from sale several years ago.
Novartis has claimed accelerated approval from the FDA for a second indication for Fabhalta – IgA nephropathy (IgAN) – as it charts a course to blockbuster sales for the drug.
Vertex and CRISPR Therapeutics have won the backing of NICE for their gene-editing therapy Casgevy as a treatment for the blood disorder beta thalassaemia, a few months after turning it dow
Shares in Novo Nordisk have gone into reverse after it reported weaker-than-expected sales of obesity therapy Wegovy, raising concerns among investors about growing competition in the categ