The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency's future regulatory ...

While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external ...

Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early ...

In addition to delivering two approved medicines to Biogen’s portfolio, the acquisition of Apellis Pharmaceuticals will ...

The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe ...

Serial biotech investor Kevin Tang previously unsuccessfully tried to buy Kezar Life Sciences via Concentra Biosciences, a ...

The recent uptick in IPOs is an encouraging signal after a drought for much of 2025. Experts point to AI as a driving force ...

Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more ...

The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall ...

While peptides are currently the dominant approach to GLP-1 agonism, Ambrosia Biosciences is pursuing a small-molecule ...

As Novo Nordisk cuts 400 jobs at the troubled site, Scholar Rock has seen enough progress that it included the facility in a ...

BioNTech envisioned the site making hundreds of millions of vaccines a year, but has since shifted its pipeline to other ...