New digital platform provides global sponsors with live visibility into R&D, process development and GMP manufacturing operations, enhancing collaboration and decision-making
The backing comes as influenza remains a persistent public health burden
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
Approval is based on results from the phase 3 OASIS 4 clinical trial
The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
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
Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval
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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