Shares of DBV Technologies surged after it received positive regulatory updates in the U.S. and Europe for its Viaskin Peanut allergy patch. The stock was up 47% to $1.03 in post-market trading on ...

As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting ...

DBV and FDA are in general agreement that the confirmatory study will need to demonstrate the effectiveness of the Viaskin ...

The retrospective study points to fewer suicidal thoughts or attempts among adolescents taking semaglutide or liraglutide.

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the Phase 3 PROTECT TrialSAN DIEGO, Oct. 17, 2024 (GLOBE NEWSWIRE) -- , (Nasdaq: TVTX) ...

At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global ...

A single COVID-19 mRNA vaccine dose provided similar protection to that conferred by a 2-dose series among immunocompetent ...

Familial hypercholesterolemia (FH) is a genetic disorder characterized by high levels of low-density lipoprotein (LDL) ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has once again snubbed Translarna ...

Affordability and mass distribution will be critical to the success of a long-lasting injectable HIV prevention drug that has ...

The opinion rejects granting conditional marketing authorization to AB Science’s masitinib as an oral add-on treatment for ALS in the EU.

CHMP upheld earlier opinions that Translarna is not of significant benefit to DMD due to nonsense mutations; European ...