Don't miss out on the latest business and technology news for chemical engineers, featuring select items in relation to Food, Pharmaceuticals & Bioengineering!
FDA approves Blueprint's Ayvakit for gastrointestinal stromal tumors
Ayvakit, or avapritinib, a kinase inhibitor developed by Blueprint Medicines, has been approved by the FDA as a treatment for unresectable or metastatic gastrointestinal stromal tumors that harbor platelet-derived growth factor receptor alpha exon 18 mutations. The approval was based on results from a clinical trial of 43 patients.
First antifungal injectable for neonates gains FDA nod
The FDA has approved the supplemental new drug application for Astellas' injectable drug Mycamine, or micafungin, the first antifungal specifically for the treatment of invasive candidiasis in infants younger than four months old. Mycamine was approved to treat bloodstream infections, acute disseminated candidiasis, candidemia and Candida peritonitis.
USDA, FDA, EPA launch joint website for agri biotech regulation
The FDA, the Department of Agriculture and the Environmental Protection Agency announced the launch of a unified biotechnology regulation website that would streamline information from the three agencies responsible for overseeing agricultural biotech products. "This new website will help provide regulatory certainty and clarity to our nation's farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and breakdown barriers for these biotechnology products in the marketplace," said EPA administrator Andrew Wheeler.
AquaBounty's transgenic salmon to go on sale this year
AquaBounty Technologies is readying its biotech salmon for commercial sale this year after receiving approval from the FDA that the transgenic fish is fit for public consumption. But one challenge would be making the salmon available in grocery stores since many US grocery chains have said they do not plan to carry the product in their stores.
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