Regulatory
The U.S. FDA has requested that Emergent BioSolutions temporarily pause production of ingredients for the Johnson & Johnson COVID-19 vaccine at their facility in Baltimore.
Amgen announced the U.S. FDA awarded Breakthrough Therapy Designation to the bemarituzumab as a first-line treatment for certain types of gastric cancer.
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.
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.
PRESS RELEASES