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At that time, there were more than 1,850 [35] lawsuits and the settlement was initially estimated pay about $58,000 per complaint. [36] Approval of the settlement required 95% of the plaintiffs to agree to settle in March 2014, [ 35 ] otherwise Merck could retract their offer. [ 37 ]
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
Women who are pregnant or breastfeeding should not take enasidenib because it may cause harm to a developing fetus or a newborn baby. [4] Enasidenib was approved for medical use in the United States in August 2017. [2] [4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [5]
This is a complete list of estrogens and formulations that are approved by the FDA Tooltip Food and Drug Administration and available in the United States. Estrogens are used as hormonal contraceptives , in hormone replacement therapy , and in the treatment of gynecological disorders .
Dostarlimab was approved for the treatment of endometrial cancer in both the United States and the European Union in April 2021. [5] [6] [11] [8] [12] Based on the Garnet trial, dostarlimab gained accelerated approval from the US Food and Drug Administration (FDA) in April 2021, [6] and full approval in February 2023. [7]
It is based on a series of tests conducted by the drug’s manufacturer, or “sponsor”—first on animals, then usually on humans over three increasingly stringent phases. All the steps along the way, which can take three to 10 years, are done in close consultation with the FDA, which reviews the testing data that the sponsor submits.
A decades-old cosmetic procedure called mesotherapy, which involves injecting unregulated mixtures of vitamins and drugs under the skin to reduce under-eye bags, is regaining popularity in the US ...
In September 2000 Danco Laboratories, a sub-licencee of the Population Council, received approval from the US Food and Drug Administration (FDA) to sell mifepristone under the brand name Mifeprex. In 2019, the first generic form of mifepristone in the United States became available, manufactured by GenBioPro .