New digital platform provides global sponsors with live visibility into R&D, process development and GMP manufacturing operations, enhancing collaboration and decision-making
Study will assess the safety and effectiveness of irreversible electroporation as a minimally invasive treatment option for benign prostatic hyperplasia (BPH)
Company introduces bioequivalent version of Edarbi for hypertension treatment following U.S. FDA approval; product recorded annual U.S. sales of USD 53.5 million
Expanded indication makes Stelo the first FDA-cleared OTC CGM for children aged two years and older with diabetes or prediabetes
Approval is based on results from the phase 3 OASIS 4 clinical trial
MeRT becomes one of the few FDA-cleared neuromodulation therapies for PTSD, using EEG biomarkers and AI to personalize treatment for patients with treatment-resistant symptoms
The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy
Based on the cumulative data from ACHIEVE-1 through ACHIEVE-5, Lilly plans to submit orforglipron for FDA approval for the treatment of type 2 diabetes by the end of the second quarter
Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations
Following the completion of the acquisition on June 3, Noctrix’s flagship product, Nidra will become part of ResMed’s broader sleep medicine portfolio
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