The U.S. Food and Drug Administration approved Arrowhead Pharmaceuticals' drug for a type of genetic disorder that causes ...

Today Emergent BioSolutions (NYSE: EBS) recognizes the 10-year anniversary of the U.S. Food and Drug Administration (FDA) approval of NARCAN® (naloxone HCl) ...

The U.S. Food and Drug Administration (FDA) has approved Epkinly (epcoritamab-bysp) plus Revlimid (lenalidomide) and Rituxan ...

In June 2024, EPKINLY monotherapy was granted accelerated approval by the FDA for the treatment of R/R FL following two or more lines of systemic therapy. With the results from the confirmatory Phase ...

Zydus won final FDA approval to market a generic version of Vumerity for adults with relapsing forms of MS and active SPMS.

With this approval, Thrombate III is the only antithrombin concentrate approved in both adults and pediatric patients with hereditary antithrombin deficiency.

AbbVie (ABBV) announced that EPKINLY, a T-cell engaging bispecific antibody administered subcutaneously, in combination with ...

The Food and Drug Administration shouldn’t be in the news if it’s doing its job right. By that measure the FDA is failing in spectacular fashion. The agency this week is making news for all of the ...

Minnow Inhalerx hopes to be first to market with inhaled synthetic medical cannabis therapies for cancer pain and panic ...

Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Redemplo, a small interfering RNA medicine, as ...

Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® ...

The indication was restricted to only patients with DMD who are 4 years of age and older with a confirmed mutation in the DMD gene; the indication for non-ambulatory patients with DMD was removed.