Food and Drug Administration (FDA)
NEWS
The agency is requesting additional information and analysis of preclinical studies regarding KVD824 before giving the go-ahead to the Phase II trial.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 20, 2021.
Opdivo, the trade name for the generic Nivolumab, can now be used in combination with certain types of chemotherapy for initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
The government agency is asking for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).
Acting FDA Commissioner Janet Woodcock shared her thoughts on pandemic issues and outlined FDA modernization plans in a recent Q&A session with the Alliance for a Stronger FDA (Alliance).
The reason for the request was the monotherapy antibody therapy is less effective against the COVID-19 variants, such as have risen from the U.K., South Africa and Brazil, as well as the growing B.1.427/B.1.429 California variant.
The U.S. FDA’s Advisory Committee on Immunization Practices (ACIP) met yesterday to make a recommendation on the current pause of the Johnson & Johnson COVID-19 vaccine.
The approval marks the second approval for Trodelvy, which Gilead gained through its $21 billion acquisition of Immunomedics.
On Tuesday, Celularity received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its off-the-shelf natural killer cell therapy for malignant gliomas.
JOBS
IN THE PRESS