Approvals
The FDA has historically tended to keep more contentious relationships with some companies private. But recently, the agency appears to be publicly scolding some biopharma companies.
It was based on data from the APOLLO trial showing the drug significantly decreased the risk of progression or death by 37% compared to dexamethasone alone.
The company said that it values the FDA’s feedback and is happy that the agency has accepted its request to provide insights on its Hepatitis B development program.
The first nonsteroidal mineralocorticoid receptor antagonist (MRA) is approved for adults with chronic kidney disease associated with type 2 diabetes.
While the drug showed significant improvement in patients on a 200mg daily dose of filgotinib, it may not be promoted in the states any time soon.
Acting commissioner of the U.S. FDA asked the independent Office of the Inspector General to investigate how the FDA and representatives of Biogen interacted prior to the FDA’s approval of the company’s Aduhelm (aducanumab) for Alzheimer’s disease.
The expanded approval was made based on positive data from a second interim analysis of the Phase II KEYNOTE-629 trial.
The FDA issued Provention a CRL that focuses on a single low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in health volunteers.
FDA greenlit Jazz Rylaze for use as a component of a chemotherapy regimen for the treatment of ALL or lymphoblastic lymphoma in pediatric and adult patients.
Life sciences news sometimes flies under the radar. So here’s a look at a few stories you may have missed.
PRESS RELEASES