Fabhalta obtained FDA and European Commission (EC) approval in December 2023 and May 2024, respectively, for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). The drug also ...

Fabhalta received its first FDA approval in December 2023 for the treatment of adults with paroxysmal nocturnal hemoglobinuria or PNH. Discovered by Novartis, Fabhalta is also being studied in a ...

The FDA on Thursday gave the green light to Uplizna in IgG4-related disease, making it the first and only approved treatment ...

This is the third FDA approval for iptacopan, which is also indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria and was granted accelerated approval for the reduction of ...

Teva and Samsung Bioepis have launched Epysqli, a cost-saving Soliris biosimilar, offering a 30% discount and new hope for ...

Inebilizumab-cdon (Uplizna; Amgen) was approved as the first and only treatment for immunoglobulin G4–related disease ...

Bayer’s Viktrakvi now has full FDA approval for the treatment of NTRK gene fusion-positive solid tumors in adults and children without a known acquired resistance mutation. The drug received ...

The FDA has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.

A final decision from the FDA is expected on July 28, 2025. Please note that Empaveli is approved in the United States for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The drug is ...

The United States Food and Drug Administration (US FDA) has approved VYKAT™ XR, a significant milestone as the first approved treatment for hyperphagia in Prader-Willi syndrome (PWS).

Fitusiran is a small interference RNA therapeutic designed to prevent bleeds in patients with hemophilia A or B by lowering antithrombin.