The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant […]
Dr Dana Telem About one in six patients undergoing hernia repair require reoperation within 10 years, according to a new research letter published March 1 in […]
Sedative-hypnotic drug products are a class of drugs used to induce and/or maintain sleep. FDA Drug Safety Communications: Prescription Insomnia Drugs (UPDATED) For prescribing information, please […]
Longstanding anxiety around use of epinephrine autoinjectors has prompted research into alternative delivery routes for this life-saving medication. Several companies presented posters on their needle-free epinephrine […]
Action FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults who have a rare form of a bone marrow disorder known as intermediate […]
Docket Number: FDA-2018-D-2777 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence The purpose […]
Docket Number: FDA-2018-D-3292 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance […]
A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the US Food and […]
Share on PinterestUnder a new FDA rule, an Alzheimer’s drug will be used only to treat people in the early stages of the disease. MoMo Productions/Getty […]
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