Food and Drug Administration (FDA)
NEWS
The regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status.
The U.S. FDA has released a Complete Response Letter (CRL) following its review of LEO Pharma’s tralokinumab. Further data on a device component is the issue brought to light by the recently completed Biologics License Application (BLA) review.
AstraZeneca’s COVID-19 vaccine road to approval has been anything but smooth.
The U.S. FDA’s Oncologic Drugs Advisory Committee did not agree in a recent meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
The U.S. FDA says it is unable to approve Biogen supplemental Biologic License Application (sBLA) for subcutaneously delivered TYSABRI® for the treatment of relapsing multiple sclerosis (MS), at least while the sBLA remains in its present form.
The FDA is threatening Acceleron with a $10,000 fine or criminal prosecution, charging the company with failure to post a summary of study data on its cancer combo dalantercept and axitinib in the ClinicalTrials.gov online database.
Moderna, one of three companies to have a COVID-19 vaccine authorized in the U.S., isn’t resting on its accomplishments but is instead working to scale up production further and improve on its vaccine.
The companies indicated they are studying the CRL to determine the best way to understand the problems and what course of action they might take.
Texas is quickly becoming a hotbed of biopharmaceutical activities, with Houston being one of the two top cities in the state that is leading the way.
JOBS
IN THE PRESS