While Johnson & Johnson isn't the first to secure FDA approval for an FcRn-blocking antibody in myasthenia gravis, the New ...

CGBIO, a South Korea-based company, earned the FDA’s investigational device exemption approval for its Novosis putty for spinal fusions. The bone graft incorporates rhBMP-2 and is designed to enhance ...

Bayer’s Vitrakvi (larotrectinib) has been granted traditional approval by the US Food and Drug Administration (FDA) to treat neurotrophic ... Tumours with NTRK gene fusion produce an altered TRK ...

With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion. "The FDA has cleared the Catamaran SI Joint Fusion System ...

Full approval of Vitrakvi was based on results from three clinical trials in patients with unresectable or metastatic NTRK fusion-positive solid tumors. “This first full approval of an NTRK inhibitor ...