The U.S. Food and Drug Administration said on Tuesday that some data from early ...
NEW YORK - The U.S. Food and Drug Administration said on Tuesday that some data from early testing of Novartis’ more than $2 million gene therapy Zolgensma was manipulated, but the agency believes the treatment should remain on the market.
The regulator plans to take action against the company including possible civil or criminal penalties. “The data in question were a small portion of our overall submission and are limited to an older process no longer in use.” The FDA said its concerns were currently limited to a small portion of product testing data included in the marketing application for the therapy.
Indonesia Berita Terbaru, Indonesia Berita utama
Similar News:Anda juga dapat membaca berita serupa dengan ini yang kami kumpulkan dari sumber berita lain.
FDA says some data testing Novartis' $2 million gene therapy was manipulatedThe U.S. Food and Drug Administration said on Tuesday that some data from early ...
Baca lebih lajut »
FDA says Novartis knew its application for $2.1 million gene therapy included errorsExperts point out that while the market has dropped sharply, it still has a long way to go before a sustainable bottom can be reached.
Baca lebih lajut »
FDA Relaxes Definition Of SmoothieWASHINGTON—In a decision with far-reaching implications for the thick-drink industry, the Food and Drug Administration announced Monday that it is relaxing the standards all chilled, blended fruit beverages must meet in order to be labeled a smoothie. “For the first time in more than 50 years of strict oversight, the federal government will now recognize any drink that is not uniformly smooth, but includes pieces of fruit less than 0.72 centimeters in diameter, as a smoothie,” FDA spokesperson Linda Furman said. “Kiwi, cherimoya, and Bartlett pear flavors are now also permitted, as well as sherbet at levels constituting no more than 8 percent of total volume.” Furman added that a new concoction sold by the Pfizer pharmaceutical company and composed entirely of blended Xanax, whiskey, and ice has been categorized by the FDA as a yogurt drink.
Baca lebih lajut »
FDA says some data testing Novartis' $2 million gene therapy was manipulatedThe U.S. Food and Drug Administration said on Tuesday that some data from early ...
Baca lebih lajut »
FDA says Novartis knew its application for $2.1 million gene therapy included errorsExperts point out that while the market has dropped sharply, it still has a long way to go before a sustainable bottom can be reached.
Baca lebih lajut »
Meghan Markle's Old Los Angeles Home for Sale for Nearly $2 MillionMeghan Markle's old house in L.A. is up for grabs.
Baca lebih lajut »