Regulatory
Please check out the biopharma industry’s COVID-19 stories that are trending for May 4, 2021.
The regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status.
This drug is made and manufactured by ViiV Healthcare and is a combination of cabotegravir and rilpivirine.
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.
A study found in India that the existing COVID-19 vaccines should be effective against the Indian variant, not just the Pfizer-BioNTech vaccine.
An investigational Alzheimer’s disease drug from Tetra Therapeutics appeared to improve language ability and learning in adults with Fragile X Syndrome, according to a new study reported in Nature Medicine.
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.
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.
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