The U.K.-based biotech is set to enter mid-stage studies for its depression drug this year, while two other GABAA modulators ...

The FDA approved Gilead’s landmark long-acting HIV treatment lenacapavir Wednesday afternoon. The drug will be marketed under ...

In combination with Eli Lilly’s tirzepatide, marketed as Zepbound for obesity, Scholar Rock’s monolonal antibody helped ...

Biotech Beyond Borders report provides a sobering snapshot of the industry’s financial health, with more and more companies ...

Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.

Senate Republicans released their version of the Trump administration’s “One Big Beautiful Bill Act” on Monday with a few ...

Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the ...

Findings that U.S. companies can sue foreign rivals despite limited business operations in the country could dissuade drug ...

Speaking at BIO 2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory ...

BioNTech said in 2022 that it faced “threats of a groundless patent infringement suit” from a company that was “unable to ...

Sanofi paid a more than 300% premium on its acquisition of Vigil Neuroscience, suggesting a fierce battle to seal the deal.

Big Pharma executives have not been shy about their desire for deals, but companies have been battling macro headwinds ...