Phase III
Shares of Cassava Sciences are up more than 5% in premarket trading after the FDA denied a Citizen Petition filed last year to suspend the company’s Alzheimer’s clinical trials.
New two-year data from Phase III studies of Susvimo and Vabysmo reinforce the two drugs’ potential to improve the quality of life of patients diagnosed with DME and nAMD.
On Feb. 15, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss an amended EUA for the Pfizer-BioNTech vaccine in the under 5 age group.
The promising results from the pediatric expansion are what fuels Novavax’s next move to apply for regulatory approval for the 12-to-17-year age group by the first quarter of 2022.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended 14-1 that the two companies conduct a trial applicable to the U.S. population.
Shares of Alnylam Pharmaceuticals are sliding in morning trading despite the news that the company’s revenues grew by 83% in 2021 compared to the previous year.
Ardelyx has reported in a regulatory filing that the FDA sent an Appeal Denied Letter for its drug tenapanor, a therapeutic intended for chronic kidney disease.
Merck has announced positive results from its Phase III KEYNOTE-522 study on the use of KEYTRUDA alongside chemotherapy in high-risk early-stage triple-negative breast cancer.
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
Endevica Bio isn’t trying to cure cancer. Instead, it is focused on improving cancer patients’ quality of life and preventing deaths.
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