FDA adds four tropical diseases to priority review voucher program to encourage drug development
- Details
- Written by Theresa Eisenman
- Category: Health News
Washington, DC - “Part of our work to protect and promote public health of Americans includes monitoring global diseases and pathogens and ensuring we have a robust pipeline of drugs and biologics to treat or prevent the spread of these infectious diseases. Today we’ve added four diseases to a program designed to encourage development of new drug and biological products to prevent or treat certain tropical diseases affecting millions of people throughout the world, including Lassa fever, which impacted more than 400 people during an outbreak in Nigeria earlier this year, killing over 100 people.
FDA approves first drug for neurotrophic keratitis, a rare eye disease
- Details
- Written by Theresa Eisenman
- Category: Health News
Washington, DC - The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).
Post Acute Medical Agrees to Pay More Than $13 Million to Settle Allegations of Kickbacks and Improper Physician Relationships
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- Written by IVN
- Category: Health News
Washington, DC - Post Acute Medical, LLC, a Pennsylvania-based operator of long‑term care and rehabilitation hospitals across the country, and certain affiliated entities through which the company operates its facilities (collectively, “PAM”), have agreed to pay the United States, Texas, and Louisiana a total of $13,168,000 to resolve claims that they violated the False Claims Act, and the Texas and Louisiana false claims statutes, by knowingly submitting claims to the Medicare and Medicaid programs that resulted from violations of the Anti‑Kickback Statute and the Physician Self‑Referral Law, the Justice Department announced Wednesday.
FDA approves first generic version of EpiPen
- Details
- Written by Angela Stark
- Category: Health News
Washington, DC - The U.S. Food and Drug Administration approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.
FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder
- Details
- Written by Tammy Wirt
- Category: Health News
Washington, DC - Friday, the U.S. Food and Drug Administration permitted marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder (OCD).
Advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
- Details
- Written by FDA Commissioner Scott Gottlieb, M.D.
- Category: Health News
Washington, DC - Over the last several years, there’s been growing scientific and public interest in the role of microorganisms in the maintenance of overall health and prevention and treatment of disease. Today, more so than ever before, consumers are familiar with the phrase “good” or “helpful” bacteria and the expectation that it will aid in treating or preventing various illnesses. As the field advances, the U.S. Food and Drug Administration is playing a key role in sorting through the science and the science fiction of this evolving field.
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