FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests
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- Category: FDA
In support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration has issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person's genomic makeup.
FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX
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- Category: FDA
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers.
FDA approves first buprenorphine implant for treatment of opioid dependence
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- Category: FDA
The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.
FDA approves new treatment for inhalation anthrax
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- Category: FDA
On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.
Launch of PRIME - Paving the way for promising medicines for patients
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- Category: EMA
The European Medicines Agency (EMA) has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).
FDA takes additional action to better understand safety of Essure, inform patients of potential risks
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- Category: FDA
The U.S. Food and Drug Administration has announced actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.
FDA providing $2 million in new grants for natural history studies in rare diseases
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- Category: FDA
The U.S. Food and Drug Administration today announced the availability of $2 million in research grants to fund natural history studies in rare diseases. The aim is to collect data on how specific rare diseases progress in individuals over time so that knowledge can inform and support product development and approval.
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