US FDA expands use of Avadel's sleep disorder drug to ages 7 and up
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and ...
FDA recalls more than 7,000 bottles of antidepressant over a possible cancerous chemical
The FDA is recalling more than 7,000 bottles of the antidepressant duloxetine due to a possible cancer-causing chemical.
FDA identifies food safety issues at Delta food preparation facility
Passengers on 200 Delta flights were denied in-flight meal service after food safety issues were discovered in the airline's ...
PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application
PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a ...
FDA and CBP Seize $76 Million in Illegal Vapes From China
Roughly 3 million units were confiscated in the operation as part of a federal crackdown on illegal e-cigarettes.
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FDA Appoints New Head of Medical Devices
The U.S. Food and Drug Administration announced Tuesday that it has appointed Dr. Michelle Tarver to head its divis ...
FDA Has Recalled Thousands of Bottles of Antidepressant Duloxetine, Sold Under Brand Name Cymbalta: Here’s Why
The Duloxetine Delayed-Release Capsules' voluntary recall began on Oct. 10 after the FDA deemed the medication the ...
The Maker of Ozempic Is Trying to Block Compounded Versions of Its Blockbuster Drug
Novo Nordisk has asked the FDA to block production of compounded copies of Ozempic, arguing that it’s too difficult to do ...
Novo Nordisk asks FDA to ban compounding pharmacies from making Ozempic, Wegovy copies
The Danish drugmaker Novo Nordisk argues that semaglutide, the active ingredient in Ozempic and Wegovy, are too complex for ...
What's with all the listeria in our food?
It has been a very busy year for food recalls in the United States. The U.S. Food and Drug Administration (FDA) and the U.S.
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PharmaTher receives CRL from FDA for ketamine ANDA
PharmaTher (PHRRF) Holdings announced that the U.S. Food and Drug Administration has issued a complete response ... The deficiencies cited in the CRL are classified as MINOR. The FDA requested new and ...
US FDA declines to approve Camurus' rare hormone disorder drug
The U.S. Food and Drug Administration has declined to approve Camurus' drug for the treatment of a rare hormonal disorder due ...