Tag: FDA
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FDA Approves RNA-Interference Nerve Disease Therapy
A treatment that silences the actions of RNA and reverses damage to nerves from a rare inherited neurological disease was approved by the Food and Drug Administration.
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FDA Issues Draft Gene Therapy Regulatory Guidance
FDA issued a series of draft documents spelling out its processes for reviewing gene therapies for three types of diseases, as well as producing and testing these treatments.
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FDA Reviewers Found Accepting Industry Payments After Drug Approvals
A new report finds a large percentage of panel members that review drug applications for the Food and Drug Administration accept payments and other rewards from companies after their drugs are approved.
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Cannabis Drug Approved by FDA for Rare, Severe Seizures
A drug based on chemicals derived from cannabis plants was approved by Food and Drug Administration for marketing in the U.S. to treat seizures associated with two rare and severe forms of epilepsy.
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FDA Issues Guidance on Patient Experience Data Collection
The Food and Drug Administration issued draft regulatory guidance outlining methods for collecting data from patients that the agency says will help improve evaluations of more precisely targeted drugs.
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FDA Delays Crispr Trial for Inherited Blood Diseases
The U.S. Food and Drug Administration put a hold on beginning a clinical trial of the emerging genome editing technique known as Crispr to treat inherited blood disorders.
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New ALS Drug Formula Shown Active, Safe
A new formulation of a current drug to treat amyotrophic lateral sclerosis, or ALS, shows in its first clinical trial the drug produces more active ingredients against ALS than the current drug and causes no safety concerns.
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FDA Okays A.I.-Guided Wrist Fracture Software
The U.S. Food and Drug Administration authorized marketing of software to help diagnose wrist fractures using machine-learning algorithms to read and interpret X-ray images.
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FDA Urges More Industry Sun Protection Research
The head of the U.S. Food and Drug Administration is asking companies making sunscreen to conduct more research on the safety of products that protect against harmful sun rays.
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Cannabis Derivative Shown to Reduce Severe Seizures
A clinical trial shows treatments made with cannabidiol, a medical-grade derivative of cannabis plants, reduce the number of severe seizures in people with Lennox–Gastaut syndrome, when combined with conventional drugs.