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Drugs Approvals and Trials

Proposals to revise guidance on first-in-human clinical trials

Comments invited on a concept paper on changes intended to support best practices The European Medicines Agency (EMA), in cooperation with the European ...

New genetic research can significantly improve drug development

With drug development costs topping $1.2bn (£850 million) to get a single treatment to the point it can be sold and used in the clinic, could genetic analysis save hundreds of millions of dollars? ... Full story

Cutting-edge Findings in Cannabis Research

New evidence for the clinical efficacy of cannabis therapy is presented in the latest issue of the Journal of Basic and Clinical Physiology and Pharmacology (JBCPP), a De Gruyter publication. The authors have studied cannabis therapy for many years at international research centers, examining its effects, potential applications, and risks. ... Full story

Better "packaging" could make drugs easier on patients

Neutron researchers explain mechanism to increase solubility of cancer drug ... Full story

FDA approves folic acid fortification of corn masa flour

The U.S. Food and Drug Administration today approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains. ... Full story

Spinal cord injury researcher seeks volunteers

UC PhD student Cindy Allison is seeking participants with spinal cord injuries for the final phase of her doctoral research. ... Full story

Cellulitis sufferers wanted for a new research survey

People who have had the painful and serious skin infection ‘cellulitis’ are being asked to help scientists design new medical research to improve treatment of the condition. ... Full story

FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality

The U.S. Food and Drug Administration today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. ... Full story

FDA proposes ban on most powdered medical gloves

Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling. ... Full story

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