One panelist who voted ‘yes,’ Gabriel Alizaidy, M.D., of Maximus Health, argued that there was a “mismatch in real-world data ...

Following in the footsteps of Gilead Sciences, Merck & Co. has signed voluntary licensing agreements to enable access to its ...

With all eyes on Tavneos’ seemingly precarious approval status in the U.S., Amgen is advancing plans to defend the ...

Novo Nordisk is escalating its legal battle against Eli Lilly over its GLP-1 drug marketing, notifying a federal court that ...

Three years after gaining three liver disease assets in its $952 million buyout of Albireo, Ipsen is struggling to develop ...

This week on “The Top Line,” Fierce Healthcare and Life Sciences’ editor-in-chief steps behind the microphone for a solo ...

Generic drugmakers will face import tariffs in the U.S., President Donald Trump announced this week. Samsung Biologics is ...

As the recent reshoring zeal rolls on in the United States, BeOne Medicines is beefing up its flagship manufacturing and R&D campus in New Jersey to the tune of $300 million.  | As the recent ...

Johnson & Johnson has unveiled massive phase 3 survival data for its dual bispecific combination in earlier-line multiple ...

Aiming to bolster ivonescimab’s case ahead of a key FDA decision, Summit Therapeutics has provided updated overall survival data from the phase 3 HARMONi trial for its PD-1xVEGF bispecific antibody.

In a landmark moment for its oncology ambitions, GSK has secured FDA approval for Jideytro (zidesamtinib) as the first ...

The FDA has called out Sanofi’s promotion of respiratory syncytial virus (RSV) antibody Beyfortus in a new untitled letter, ...