“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Dr. Robert Califf said in a statement.
“While we stand by Makena’s favorable risk-benefit profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Covis Pharma Chief Innovation Officer Dr. Raghav Chari said in a news release at the time.
Where the hell is your coverage of the fascism going on in Tennessee? A democratically elected law maker was just expelled for peacefully protesting gun violence with his constituents after yet another mass murder had occurred not far away. Shame on you. TenneseeThree
So ….are they confessing that they fed pregnant women placebo pills for the last 10 years or are they removing the opportunity to actually save a pregnant women and their unborn fetus from risky premature birth …please explain
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FDA forces unproven premature birth drug Makena off marketThe FDA orders the immediate market withdrawal of Makena, a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women. Classic FDA. Bought and paid for by Big Pharma since 1992. Now do the covid vax US_FDA will approve this dangerous drug for 12 years while safe and effective NurOwn for 100% fatal disease ALS is blocked by FDACBER. PALS DiedWaiting DyingWaiting MakesNoSense katiecouric USNewsHealth WSJhealth SenSusanCollins POTUS SenatorBraun lisamurkowski
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