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
Corning and SGD Pharma formed JV in June 2023 to expand pharmaceutical manufacturing in India
No post-injection Delirium/Sedation Syndrome (PDSS) observed through 56 weeks
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
Importantly, the combination of giredestrant and everolimus was well tolerated
Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent
Conducted entirely in Europe across forty sites in five countries, this rigorous study met all clinical endpoints
The inspection concluded with zero form 483 observations
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