Potentially “groundbreaking” FDA gene therapy pathway leaves key issues unresolved
The US Food and Drug Administration’s (FDA’s) new pathway for gene therapies could be “groundbreaking” if applied broadly, though the…
The US Food and Drug Administration’s (FDA’s) new pathway for gene therapies could be “groundbreaking” if applied broadly, though the…
Amid the European Commission’s (EC’s) public consultation on the EU Biotech Act, EuropaBio has called for the EU to adopt…
Novo Nordisk’s oral therapy Wegovy (semaglutide) reduced cardiovascular risk factors in the Phase III OASIS 4 trial. Being used by…
Novo Nordisk has raised its offer to buy out obesity biotech Metsera to $10bn as a bidding war with Pfizer…
Aldeyra Therapeutics has reshuffled its pipeline, terminating the development of a Phase II asset despite meeting its endpoints in alcohol-associated…
Eli Lilly and Incyte’s oral JAK inhibitor has shown benefit in hair regrowth in paediatric patients with severe alopecia areata.…
Pharmaceutical research and development (R&D) is unlikely to be significantly impacted by most favored nation (MFN) pricing, according to industry…
Eli Lilly’s Omvoh (mirikizumab-mrkz) has shown continued benefit after four years in a Phase III open-label extension trial in patients…
The US Food and Drug Administration (FDA) has released its clinical hold on Neurizon Therapeutics’ NUZ‑001, paving the way for…
Amgen is hopeful that Phase III data will cement the validity of its recently approved widened label for cholesterol-lowering drug…