The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
Sessions will cover process mapping, cost optimisation, data-driven decision-making, cybersecurity, and sustainable manufacturing practices
Agency initiates safety label change and notifies physicians of possible link
All drug substance for Moderna’s authorized Spikevax (COVID-19 mRNA vaccine) targeting the SARS-CoV-2 LP.8.1 variant is produced at the company’s facility in Laval, Quebec
Clinical evidence has consistently highlighted lacosamide’s efficacy and safety.
Collaboration matches more eligible patients, including those with rare and complex diseases, to appropriate clinical trials
This predictive technology empowers people with diabetes to take preventive action before complications arise
Funding supports development of first-in-class pan-ROCK inhibitor ROC-101 through Phase 2a clinical testing
Conducted entirely in Europe across forty sites in five countries, this rigorous study met all clinical endpoints
The TULIP-SC trial investigated the efficacy and safety of subcutaneous Saphnelo
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