Por: ABC News Health March 08, 2023
WASHINGTON -- The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the U.S., after regulators signaled plans to follow through on a long-delayed effort to force it from the market.The drug, Makena, is a synthetic version of the hormone progesterone, which is needed to maintain a pregnancy. It’s the only drug with FDA approval to reduce the risk of premature birth.The removal... + full article
Los Angeles Times USA 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... + 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
Associated Press USA Politics March 08, 2023
WASHINGTON (AP) — The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the U.S., after regulators signaled plans to follow through on a long-delayed effort to .The drug, Makena, is a synthetic version of the... + más
FDA holds hearing to remove pregnancy drug from market, company pushes back | WGN-TV
Maker of unproven birth drug Makena to pull from US market | ABC News
Portland Press Herald USA Health October 19, 2022
WASHINGTON — Federal health advisers have concluded that a drug intended to prevent premature births hasn’t been shown to work, clearing the way for U.S. regulators to follow through on a long-delayed effort to get it off the market. A panel of federal advisers says Makena,... + más
FDA panel backs removal of unproven pregnancy drug | WPLG Local 10
FDA panel backs removal of unproven pregnancy drug | 10 WBNS
NBC 6 South Florida USA World October 19, 2022
Makena Federal health advisers have concluded that a drug intended to prevent premature births hasn't been shown to work, clearing the way for U.S. regulators to follow through on a long-delayed effort to get it off the market. The ’s advisory panel voted 14-1 Wednesday... + más
FDA panel recommends revoking the approval of controversial drug intended to prevent premature birth | CNBC
FDA panel backs removal of unproven pregnancy drug | Portland Press Herald
WGN-TV USA Nation October 17, 2022
WASHINGTON (AP) — The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn’t work. A Food and Drug Administration meeting that opened... + más
ALS drug wins FDA approval despite questionable data | ABC News
FDA pushes to remove pregnancy drug, company pushes back | WPLG Local 10
WPLG Local 10 USA Politics October 17, 2022
WASHINGTON – The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn't work.A Food and Drug Administration meeting that opened Monday... + más
FDA pushes to remove pregnancy drug, company pushes back | ABC News
NBC 6 South Florida USA World October 17, 2022
AP FILE – This Oct. 14, 2015, file photo, shows the Food & Drug Administration campus in Silver Spring, Md. Despite new legal powers to compel recalls and sophisticated technology to fingerprint pathogens, the Food and Drug Administration allowed some food-safety... + más
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