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

Cinryze is the first product to be approved by the FDA for the routine prophylaxis of ... be fully trained and productive enough to carry a full workload because of the complexity of the work ...

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

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, raising questions about its future in the market. US FDA declines full ...

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 ...

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 ...

Ultromics Ltd. received clearance from the U.S. FDA for Echogo Amyloidosis, its artificial intelligence-enhanced software ...

The FDA has approved a new treatment, Aucatzyl, for a type of aggressive blood cancer called B-cell acute lymphoblastic leukemia (B-cell ALL). This treatment, a CAR T-cell immunotherapy ...

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 ...

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 ...