Analysts suggested the efficacy of Trutakna looks overall consistent with its closest competitor, Otsuka’s Voyxact, but more ...

FDA's approval playbook for ultra-rare genetic diseases is not one-size-fits-all, CDER's director said, and rare disease ...

Lawmakers outside the House and Senate health committees may try to leverage the user fee bill to curb China’s role in ...

The European Medicines Agency is set to decide whether to recommend EU marketing approval for 11 new medicines, including two ...

Novo is set to learn whether the European Medicines Agency’s human medicines committee will back its hemophilia A drug for EU ...

Pharmaceutical product valuation needs assumptions that include market share, compliance and diagnosis rates. These need to ...

Brazil's Hypera has launched GLP-1 semaglutide and a companion dietary supplement range under the same brand name. Experts ...

The voluntary deals now reach most of the US branded market even as the scope of each agreement remains somewhat opaque.

Phase II miss in MDD comes less than a year after Phase II failure with the same drug in multiple sclerosis. Analysts say ...

Questions are the kind administration leadership can expect if Democrats retake control of the House or Senate after the ...

While Carvykti has lots of growth span ahead of it, the former Novartis executive will be tasked with building Legend’s next ...

PA, the first-ever dual-functional RNAi therapeutic, provide initial validation for the company’s approach to silencing two ...