The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

For the second time this year, Leo Pharma has struck a partnership with a major drugmaker, this time paying Boehringer ...

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

Bristol Myers Squibb has opened its radiopharmaceutical manufacturing facility in Indianapolis, which played a major role in ...

It may not be an Olympic year, but Humana is still firing up some competition this summer. | It may not be an Olympic year, ...

After resolving a patent dispute with Incyte, Sun Pharma has officially launched its JAK inhibitor Leqselvi in the U.S. | Sun ...

The use of SGLT2 inhibitors has been a game-changer in the treatment of heart failure (HF). Now, another drug class has ...

A weekend focused on women’s health and women’s basketball, all in Eli Lilly’s home state of Indiana? Consider that a layup ...

As Azurity Pharmaceuticals rethinks its manufacturing footprint, the privately held company is parting ways with a clutch of ...

Varda Space Industries, which is leveraging reusable rockets to manufacture drugs in low Earth orbit, has received more fuel for its endeavors in the form of a $187 million series C fundraising haul.

While Astellas’ Veozah was the first neurokinin 3 (NK-3) receptor antagonist approved for menopause, Lynkuet is the first ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...