FDA
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.
KnipBio Inc. announced it has received Generally Regarded As Safe designation from the US Food and Drug Administration Center for Veterinary Medicine for its KnipBio Meal aquafeed ingredient for salmonids and other finfish species.
Two of the three drugs that were up for review in mid- to late-February received much earlier approval in December 21, the day before the federal government shutdown. The shutdown ended on January 25, 2019.
Novartis announced that the FDA approved the company’s Egaten to treat fascioliasis in patients six years of age and older. Novartis also inked a multi-target and multi-year collaboration with AbCellera.
Darzalex (daratumumab) for intravenous infusion is approved in the U.S. in combination with bortezomib, melphalan and prednisone for patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant.
It’s not exactly breaking news that biopharma companies are increasingly turning toward machine learning and artificial intelligence (AI) to improve drug development. What is big news is how resoundingly it might improve on traditional methods.
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