Approvals
The FDA and CDC will soon decide on Pfizer-BioNTech’s request for an Emergency Use Authorization for the booster shot for their COVID-19 vaccine.
The research showed that 61% of patients with PV experienced a complete hematological response after 7.5 years of treatment with BESREMi. Here’s more about it.
Pfizer and BioNTech requested the FDA authorize booster shots for their COVID-19 vaccine for all adults 18 years and older, presenting data not available in September.
Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.
Ardelyx, Inc. is lacing up the gloves and preparing to wade into the ring with the U.S. Food and Drug Administration to dispute the July rejection of its chronic kidney disease drug, tenapanor.
Pfizer plans to seek Emergency Use Authorization for an antiviral COVID-19 treatment following an interim analysis of Phase II/III data that show statistically and clinically meaningful results.
This week, the U.S. Food and Drug Administration accepted Investigational New Drug Applications for multiple companies, clearing the way for clinical development.
The drug makers have until February 28, 2022 to review their findings and analytical processes for the drug they are developing to treat relapsed and/or refractory multiple myeloma.
The decision made VUITY the very first and only eye drop to be approved for the Presbyopia treatment. Follow the article to know aspects of this new treatment.
Scemblix is the first-in-class FDA-approved treatment for adult patients diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia.
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