Novartis and its Fabhalta may have been first to the punch in ultrarare kidney disease complement 3 glomerulopathy (C3G), but ...

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

The injectable production specialist has snapped up a 65-acre property with more than 300,000 square feet of usable space to ...

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

After what Bavarian Nordic described as “intense negotiations,” the Danish vaccines maker has agreed to be acquired by a ...

After purging the CDC’s vaccine advisory committee and replacing it with his own appointments, U.S. Health Secretary Robert F ...

A recently launched video series from the Biotechnology Innovation Organization (BIO) seeks to show how biotech may be able ...

After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet ...

The importance of a homegrown biomanufacturing workforce to North Carolina’s swiftly growing life sciences industry was a consistent theme during a recent press tour of the state attended by Fierce | ...

Moderna has scrapped plans to build an mRNA plant in Japan. Otsuka and Lundbeck's proposal for Rexulti as part of a PTSD ...

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...