Glenmark’s Ropivacaine Hydrochloride Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug Naropin Injection of Fresenius Kabi USA
Vaccine efficacy against primary CMV infection ranged from 6 per cent to 23 per cent, depending on case definition, falling short of Moderna’s predefined target
The submissions are supported by data from the Phase 3 KEYNOTE-905 trial
Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone
The combination is approved for advanced endometrial carcinoma that is pMMR or not MSI-H and has progressed after prior systemic therapy
The SELECT-SWITCH study, first head-to-head Phase 3b/4 trial, compared switching to Rinvoq versus switching to another TNF inhibitor
Expanding US operations to address the increased demand for API development and manufacturing
The initial $100 million will fund a state-of-the-art hard-shell capsule facility in Atlanta
XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in this patient population, supporting its earlier use in this setting
The expansion underscores Merck’s commitment to invest more than $70 billion in U.S. research, development and capital projects
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