Approvals
The U.S. Food and Drug Administration has been busy approving new treatments for various diseases. Two days into the new week and the regulatory agency has green lit two therapeutics, while other companies are planning to file for potential approval.
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It blocks interactions with both PD-1 and B7.1 receptors.
The next couple of weeks look to be busy for the FDA, with a string of target action dates scheduled. This week marks three scheduled approvals, two for extra indications for already-approved biologics, and the third for a combination treatment for glaucoma. Here’s a look.
Janssen believes the treatment works by restoring synaptic connections in brain cells in individuals with major depressive disorder.
Evaluate recently published the Vantage Pharma, Biotech and Medtech 2018 in review report. The annual report offers insights into the previous year’s activities in biopharma and the medical device industry.
MorphoSys AG announced that its licensee Janssen Research & Development, LLC, has reported that the U.S. Food and Drug Administration has approved Tremfya One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis.
FDA Approval Allows Interventional Cardiologists Access to Resolute DES Technology to Treat De Novo CTO
Medtronic plc, the global leader in medical technology, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration for its Personalized Closed Loop insulin pump system, currently in development.
On Tuesday, Novo Nordisk said the FDA approved its Biologics License Application for Esperoct (turoctocog alfa pegol) formerly known as N8-GP, for the treatment of children and adults with hemophilia A.
Intercept Pharma plans to seek regulatory approval in the U.S. and Europe in the second half of this year.
PRESS RELEASES