Pfizer Inc. and its German partner BioNTech SE said on Monday they have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization of their Omicron-adapted COVID-19 vaccine booster for children aged 6 months through 4 years.
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Ionis Pharmaceuticals Inc. announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for review of tofersen, an investigational medicine for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). SOD1-ALS is a progressive and uniformly fatal disease that affects fewer than 1,000 people across Europe.
Vaccines company Valneva on Monday reported positive 12-month antibody persistence data for its single-shot Chikungunya vaccine candidate.
Amgen Inc.’s experimental obesity drug demonstrated promising durability trends in an early trial, paving the way for a larger mid-stage study early next year, company officials said ahead of a data presentation on Saturday.
Mpox is expected to no longer be considered a public health emergency in the United States from Feb. 1, 2023, the U.S. health department said on Friday.
GSK plans to file for approval of Jemperli in endometrial cancer after the checkpoint inhibitor met its primary endpoint in the Phase III RUBY trial, the company announced Friday.
Gaps in surveillance, testing, sequencing, and vaccination for COVID-19 could create the perfect storm for a new variant.
Athira Pharma’s experimental Alzheimer’s therapy, fosgonimeton, continues to show signs of being able to improve cognition and function in patients.
Adding to yesterday’s announcement of a $1.26 billion investment in Dublin, the company said it plans to match that investment to expand its Puurs, Belgium manufacturing site.
“We believe that subcutaneous formulation has the potential to be novel, non-obvious and useful, which means we would get a new patent for it,” according to Merck CFO Caroline Litchfield.