The FDA says product testing data for Novartis gene therapy drug was manipulated
WASHINGTON—The Food and Drug Administration said “data manipulation” took place during company studies of Zolgensma, the world’s most expensive drug, but officials said the gene-therapy product still should stay on the market.
The medicine, which costs in the range of $2.1 million for a one-time infusion, treats children with an especially devastating, sometimes fatal form of spinal muscular atrophy. The FDA said it was informed after the May 24 approval of the drug that there had been a data-manipulation issue. That information...
Singapore Latest News, Singapore Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
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 ...
Read more »
U.S. 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 ...
Read more »
Boom in overdose-reversing drug is tied to fewer drug deathsPrescriptions of the overdose-reversing drug naloxone are soaring, and experts say that could be a reason overdose deaths have stopped rising for the first time in nearly three decades. The number of naloxone prescriptions dispensed by U.S. retail pharmacies doubled from 2017 to last year, rising from
Read more »
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.
Read more »
Basketball player suspended after drug test says he's pregnantD.J. Cooper, who garnered national attention early in his career, had been playing internationally for teams in Greece, France and Russia.
Read more »
Decline in opioid deaths is tied to growing use of overdose-reversing drug, CDC saysPrescriptions are way up for a drug that reverses the effects of an opioid overdose. That could help explain the recent decline in fatal opioid overdoses.
Read more »