FDA
BioNTech inked an exclusive worldwide license and collaboration agreement with OncoC4 to develop and commercialize its investigational anti-CTLA-4 antibody ONC-392 for solid tumors.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
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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.
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for children ages 5 to 11.
Yet another busy week for clinical trial news. Here’s a look.
Paris-based Sanofi reported its third-quarter finances, with most of its categories showing strong growth. However, not everything was rosy
Emergent BioSolutions, the manufacturer responsible for the doses in question, is reportedly just waiting for the U.S. FDA’s signal to start shipping the vaccines.