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Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe: Drug exposure and clinical response variability Risk for adverse events Genotype-specific dosing Mechanisms of drug action Polymorphic drug target and disposition genes The table below lists FDA-approved drugs with pharmacogenomic information in their labeling. The labeling for some, but not all, of the products includes specific actions to be taken based on the biomarker information. Pharmacogenomic information can appear in different sections of the labeling depending on the actions. For more information, please refer to the appropriate labeling guidance.

Federal regulators on Thursday approved a genetically engineered salmon as fit for consumption, making it the first genetically altered animal to be cleared for American supermarkets and dinner tables. The approval by the Food and Drug Administration caps a long struggle for AquaBounty Technologies, a small company that first approached the F.D.A. about approval in the 1990s. The agency made its initial determination that the fish would be safe to eat and for the environment more than five years ago.

The US Food and Drug Administration has approved a first-of-a-kind drug that uses the herpes virus to infiltrate deadly skin cancer tumours, reducing their size in some cases.

The Food and Drug Administration just approved the AquAdvantage Salmon, a fish genetically engineered to grow more quickly than its conventional counterparts. It's the first GMO animal for human consumption approved for sale in the United States.

Based on a comprehensive analysis of the scientific evidence, as required by the Federal Food, Drug and Cosmetic Act (FD&C Act), the FDA has determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the FD&C Act. The salmon are safe to eat, the introduced DNA is safe for the fish itself, and the salmon meet the sponsor's claim about faster growth. Because the sponsor has met these requirements, the FDA must approve the application. The FDA has also analyzed the potential environmental impact that an approval of the AquAdvantage Salmon application would have on the quality of the human environment in the United States and has issued its final Environmental Assessment and Finding of No Significant Impact.

This clicker case was designed to teach students about basic enzyme structure, mechanisms of enzyme inhibition, and mechanisms of drug resistance. The story follows Oliver Casey, a patient afflicted with Chronic Myelogenous Leukemia (CML). CML is caused by a chromosomal mutation that affects the tyrosine kinase ABL, an enzyme important in regulating cell growth and proliferation. The chromosomal mutation gives rise to the BCR-ABL fusion gene that produces a constitutively active ABL kinase, which causes the leukemia. In May 2001, the Food and Drug Administration approved the use of a rationally designed tyrosine kinase inhibitor, imatinib (Gleevec®), for the treatment of CML. During that same month, Gleevec made the cover of TIME magazine, described as "new ammunition in the war on cancer." The case is structured for a flipped classroom environment in which students view preparatory videos (including one by the author) on their own before beginning the case. Written for a first-year introductory biology course, the case could also be adapted for AP/Honors high school biology or a cancer biology course.

Thus began a fateful test of wills. Merrell responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey's bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug - better known by its generic name, thalidomide - was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.

A multicenter study has identified an FDA-approved medication that prolongs survival in mice with diffuse intrinsic pontine glioma, a brain tumor that now lacks chemotherapy treatments.

A kind of salmon that's been genetically modified so that it grows faster may be on the way to a supermarket near you. The Food and Drug Administration approved the fish on Thursday - a decision that environmental and food-safety groups are vowing to fight. This new kind of fast-growing salmon was actually created 25 years ago by Massachusetts-based AquaBounty Technologies. A new gene was inserted into fertilized salmon eggs - it boosted production of a fish growth hormone. The result: a fish that grows twice as fast as its conventional, farm-raised counterpart.

We all know Sally: She is our daughter, our sister, our friend -- her health in the balance. In that moment, we're all looking for a solution, some hope. This 60-second spot begins and ends in Sally's hospital room. It takes us back in time to see the many people who contributed to the discovery, development, and approval of lifesaving medicine. Directed by Steve Dorst.