One panelist who voted ‘yes,’ Gabriel Alizaidy, M.D., of Maximus Health, argued that there was a “mismatch in real-world data” on the peptide’s use versus what the FDA had presented, calling the ...

With all eyes on Tavneos’ seemingly precarious approval status in the U.S., Amgen is advancing plans to defend the ANCA-associated vasculitis (AAV) drug it inherited in its $3.7 billion buyout of ...

Following in the footsteps of Gilead Sciences, Merck & Co. has signed voluntary licensing agreements to enable access to its investigational HIV PrEP pill alimatravir. The New Jersey pharma is ...

Three years after gaining three liver disease assets in its $952 million buyout of Albireo, Ipsen is struggling to develop the trio. In May, the company grounded two investigational candidates. And ...

Generic drugmakers will face import tariffs in the U.S., President Donald Trump announced this week. Samsung Biologics is pursuing the biggest M&A deal ever for a Korean biopharma company. | Generic ...

Novo Nordisk is escalating its legal battle against Eli Lilly over its GLP-1 drug marketing, notifying a federal court that it plans to seek a preliminary injunction that would stop its obesity riv | ...

This week on “The Top Line,” Fierce Healthcare and Life Sciences’ editor-in-chief steps behind the microphone for a solo episode highlighting several of the biggest stories in biopharma. | This week ...

Johnson & Johnson has unveiled massive phase 3 survival data for its dual bispecific combination in earlier-line multiple myeloma, delivering another catalyst that could add a new twist in the ...

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 ...

The FDA has called out Sanofi’s promotion of respiratory syncytial virus (RSV) antibody Beyfortus in a new untitled letter, taking issue with the company’s characterization of the med as a general | ...

While the White House focused its initial Section 232 pharmaceutical tariffs on branded drugs, generics makers—who supply the vast majority of U.S. prescriptions—won’t stay in the clear for long.  In ...

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.