Summary FDA has received reports of allergic-type reactions potentially related to sulfite-containing compounded drugs. FDA is alerting health care professionals, compounders and patients about the risk […]
CDER has established an Exclusivity Board to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency […]
What We Do The Division of Applied Regulatory Science (DARS) moves new science into the FDA regulatory process and addresses emergent regulatory and public health questions. […]
Now that semaglutide (Wegovy), tirzepatide (Zepbound), and other injectables have created an insatiable market for weight loss drugs, biotech and pharmaceutical companies are roaring ahead with […]
Despite overall declines in cancer incidence and mortality, population growth and aging are predicted to drive an increase in the absolute number of people receiving a […]
A US Food and Drug Administration (FDA) expert panel has found that the benefits of the psychedelic midomafetamine (MDMA) in combination with psychological intervention for the […]
NASHVILLE, Tennessee — Interventions that stimulate the reward system may be the most effective treatment for fatigue directly related to multiple sclerosis (MS), experts said. Here […]
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