Por: Los Angeles Times Business March 08, 2023
A pharmaceutical company selling the only drug approved to prevent preterm birth said Tuesday that it would withdraw the medicine from the market. Covis Pharma said it told the Food and Drug Administration that it would voluntarily withdraw the medicine called Makena, which a study in 2019 showed did not work to extend pregnancies. “While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of... + full article
The New York Times USA Health March 08, 2023
The company that makes Makena, the only drug aimed at preventing preterm birth, announced on Tuesday that it was voluntarily pulling the medication off the market after advisers for the Food and Drug Administration concluded that the treatment did not help pregnant women at... + más
US gets D+ grade for rising preterm birth rates, new report finds | CNN
FDA panel recommends pulling preterm birth drug from the market | The Boston Globe
CNN USA Health November 15, 2022
CNN — The rate of premature birth in the United States is climbing, according to the infant and maternal health nonprofit March of Dimes. On Tuesday, the organization released its , which involves a newly updated calculation system. Taking an in-depth look at premature... + más
F.D.A. Panel Recommends Pulling Preterm Birth Drug From the Market | The New York Times
Time USA Life October 28, 2022
Every day, as I rush to preterm deliveries on the labor floor of my safety-net hospital and work beside incubators and clear plastic hospital bassinets, one of my patients’ mothers confides to me her belief that if she had only done that one thing differently during pregnancy,... + más
The New York Times USA Health October 20, 2022
A Food and Drug Administration advisory committee on Wednesday recommended removing the drug Makena from the market, after years of study showed the fast-tracked drug had failed to prevent preterm births.Makena has been in use for 11 years, and the panel’s vote was widely of... + más
FDA panel recommends revoking the approval of controversial drug intended to prevent premature birth | CNBC
The Boston Globe USA Nation October 20, 2022
A Food and Drug Administration advisory committee on Wednesday recommended removing the drug Makena from the market, after years of study showed the fast-tracked drug had failed to prevent preterm birth.Makena has been in use for 11 years, and the panel’s vote was widely... + más
Los Angeles Times USA Science October 20, 2022
A federal advisory panel voted Wednesday to recommend that the only approved drug to prevent premature birth be removed from pharmacy shelves because studies have shown it does not work. The 14-to-1 vote came more than a decade after the Food and Drug Administration approved the... + más
FDA panel backs removal of unproven pregnancy drug | Portland Press Herald
CNBC USA Health October 19, 2022
An advisory panel to the Food and Drug Administration voted Wednesday to take a drug intended to prevent premature births off the market, saying that it remains doubtful that the drug works.The recommendation, in a 14-1 vote, from the agency's Obstetrics, Reproductive and... + más
FDA panel backs removal of unproven pregnancy drug | WPLG Local 10
ALS drug wins FDA approval despite questionable data | ABC News
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