Por: ABC News Health April 06, 2023
WASHINGTON -- The Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn't help pregnant women.The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. The medication was the only drug approved in the U.S. to help... + full article
Time USA Health April 07, 2023
WASHINGTON — The Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women. The decision follows repeated efforts... + 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
ABC News USA 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... + más
Maker of unproven birth drug Makena to pull from US market | Associated Press
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
WPLG Local 10 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.The Food and Drug Administration’s... + más
FDA panel backs removal of unproven pregnancy drug | 10 WBNS
FDA panel backs removal of unproven pregnancy drug | 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
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
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