This study evaluated copanlisib plus nivolumab in adults with advanced solid tumors. Patients and Methods: In this phase Ib, nonrandomized, open-label, dose-escalation study, patients received ...

The FDA defines a biosimilar as a biological product that is highly similar to an FDA-approved brand-name biologic drug (known as the reference product) used in the prevention or treatment of disease.

Endoscopic augmentation of the lower oesophageal sphincter using hydrogel implants for the treatment of gastro-oesophageal reflux disease IPG222 27 June 2007 27 June 2007 Carmustine implants and ...

The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation ...

Biotechnology firm Biocon Ltd on Friday (March 7) said its subsidiary Biocon Biologics Ltd has announced positive results from its phase 3 clinical trial for Yesintek, a biosimilar to ustekinumab ...

The FDA has granted PYX-201 fast track designation for treatment of recurrent or metastatic HNSCC after progression post-chemoimmunotherapy. PYX-201 received FDA fast track designation for use in ...

Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis). Omlyclo was approved to treat the same conditions as Xolair. The FDA approved Celltrion’s omalizumab ...

On February 28, Amgen, Inc. (“Amgen”) filed three petitions for inter partes review, challenging the validity of all claims in three patents assigned to Bristol-Myers Squibb Co. (“BMS”).

The products are expected to be available in June 2025. The US Food and Drug Administration (FDA) has approved Stoboclo (denosumab-bmwo), a biosimilar to Prolia (denosumab), and Osenvelt ...

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At the same time, 90% of U.S. prescriptions are either generics or biosimilars saving the U.S. healthcare system $445 billion in 2023 alone. Despite these achievements, there are important reforms ...