A committee for the US Food and Drug Administration now recommends that the approval of Makena, a drug used to reduce the risk of preterm births, should be withdrawn — and some women who have used the medication are sounding the alarm
A committee for the US Food and Drug Administration now recommends that the approval of Makena, a drug used to reduce the risk of preterm births, should be withdrawn -- and some women who have used the medication are sounding the alarm.
Blood tests to predict preterm birth risk raise excitement -- and questionsThe 9-7 vote, which took place at a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee on Tuesday, came in response to evidence suggesting that the drug was not effective.The committee serves as an advisory group to the FDA and the voting results are not binding, said Dr.
The medication now remains in limbo until the FDA makes a final decision based on its committee's new recommendations."I predict FDA will remove the drug from the market, since the confirmatory trial showed no benefit, and removing the drug does not necessarily completely eliminate the opportunity for some women to receive the therapy," Gellad said."There is an 80% chance I will be right.
France Dernières Nouvelles, France Actualités
Similar News:Vous pouvez également lire des articles d'actualité similaires à celui-ci que nous avons collectés auprès d'autres sources d'information.
Exclusive: J&J's own expert, working for FDA, found asbestos in Baby PowderEXCLUSIVE: Ever since J&J disclosed that a government test found asbestos in its Baby Powder, the company has attacked the validity of the result. In challenging the FDA’s finding, however, the healthcare giant is casting doubt on one of its own experts
Lire la suite »
FDA approves new breakthrough therapy for cystic fibrosisWe are excited about this new therapy for CF. By maximizing detection across ethnicities for serious heritable conditions like CF, Foresight helps couples identify risk early so they can plan and prepare. Learn more about Foresight:
Lire la suite »
Cramer: This biotech stock could be worth over $100 billion on an FDA approvalBiogen, with a $54.1 billion market cap, 'could be worth twice that if all goes well' with regulators, Jim Cramer says.
Lire la suite »
FDA issues Halloween warning: Decorative contact lenses can cause blindness, infection, cornea scratches'Wouldn't it be cool to have vampire eyes for Halloween? Or deep violet eyes to match your purple sweater? How about your favorite sports team's logo on your eyes just for fun?' the FDA warning begins.
Lire la suite »
Congress, grappling with tainted Chinese drugs, is baffled by the lack of FDA oversight in the U.S. pharmaceutical supply chainFollowing major recalls of Chinese-manufactured medication that contained carcinogenic ingredients, lawmakers expressed their alarm, and sometimes disbelief, at the FDA's inability to regulate foreign suppliers at a Tuesday hearing.
Lire la suite »
Calm down, doggy. FDA approves generic drug for separation anxietyThe medication is for pups who fear being left alone.
Lire la suite »