Government
The U.S. FDA Oncologic Drugs Advisory Committee voted against recommending the drug as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery, at least for now.
This combination therapy has been authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.
The choice for the new FDA commissioner will tell the public about the Biden administration’s battle plan with regards to handling the global pandemic.
London-based Freeline Therapeutics announced that after receiving feedback from the U.S. Food and Drug Administration (FDA), it was modifying its clinical trial program for FLT180a for Hemophilia B.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 9, 2021.
Bristol Myers picked up the therapy when it acquired Celgene in 2019 for $74 billion.
Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.
The U.S. Food and Drug Administration (FDA) granted Merck KGaA, Darmstadt, Germany’s Tepmetko (tepotinib) approval for adults with metastatic non-small cell lung cancer (NSCLC) who have a MET exon 14 skipping alteration.
For the pharmaceutical industry, the lack of face-to-face meetings caused the U.S. Food and Drug Administration to implement regulatory workarounds to stay on top of drug and biologics approvals.
There were two reported cases of trials restarting and one pausing this week. Here’s a look.
PRESS RELEASES