The FDA in 2016 granted accelerated approval to the FXR agonist as a second-line treatment for adults with PBC, either in ...

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...

AstraZeneca faces challenges in securing full FDA approval for Andexxa, its anticoagulant reversal therapy, due to safety ...

Imkeldi is a new formulation of imatinib approved as a strawberry-flavored, shelf-stable liquid designed to be more appealing ...

Intercept Pharmaceuticals’ bid to win full approval for its liver disease drug Ocaliva has come up short. Intercept on Tuesday revealed that it received a complete response letter from the FDA ...

The FDA decision comes in the wake of a negative AdCom opinion in September. Image credit: Shutterstock/ Dilok Klaisataporn. On the heels of an unfavourable advisory committee (AdCom) meeting, the US ...

The new drug, Ziihera, could net Zymeworks more than $1 billion just in milestone payments, and millions more in royalties, upon full commercialization. Gaining the FDA’s accelerated approval ...

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca's top-selling respiratory drug Symbicort, although launch plans remain ...

A new therapy for brittle type 1 diabetes, the only treatment currently approved by the U.S. Food and Drug Administration, is ...

According to the CRL, the FDA is continuing to assess the safety ... The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial ...

Acoramidis is the first FDA-approved treatment for ATTR-CM with near-complete TTR stabilization, reducing cardiovascular death and hospitalization. The phase 3 ATTRibute-CM trial showed acoramidis ...

This extension was granted because we were able to demonstrate that the company is making active progress toward proving ‘substantial evidence of effectiveness' of Canalevia-CA1 for treatment of CID ...