X4 Pharmaceuticals Receives Orphan Drug Designation from the US FDA for X4P-001-RD for the Treatment of WHIM …

X4 Pharmaceuticals Receives Orphan Drug Designation from the US FDA for X4P-001-RD for the Treatment of WHIM …

CAMBRIDGE, Mass.–(BUSINESS WIRE)–X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 antagonist drugs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the Company’s drug candidate, X4P-001-RD for the treatment of WHIM syndrome, a primary immunodeficiency disease for which there are currently no approved treatments for patients. […]

Approve First, Ask Questions Later: 'Post-Marketing' Research and the FDA

Approve First, Ask Questions Later: 'Post-Marketing' Research and the FDA

The pharmaceutical company Pfizer spent more than $33 million on television advertisements for Lyrica, its blockbuster drug used to treat diabetic nerve pain and fibromyalgia, in September 2017. The drug consistently tops the lists of the most expensive marketing campaigns — the company spent $23.1 million in March 2018, and $19.5 million in April 2018. […]

Study finds the FDA allows tainted supplements to be sold in US

Study finds the FDA allows tainted supplements to be sold in US

The FDA has identified the tainted over-the-counter products, but according to new research published Friday in JAMA Network Open, over half the time, the study found, the FDA doesn’t enforce recalls of supplements that knowingly include unapproved prescription drug ingredients. Gizmodo notes that the FDA does regularly screen supplement products for unapproved pharmaceutical ingredients, usually […]

FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities

FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities

On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000 pharmaceutical sites worldwide. Of these sites, over 3000 are based outside of the United States. This large number of ex-U.S. sites requires a regulatory scheme […]

FDA warns e-cigarette makers against marketing to children

FDA warns e-cigarette makers against marketing to children

Oct. 12 (UPI) — The U.S. Food and Drug Administration sent letters Friday to e-cigarette makers and importers, warning that it will remove any products that have been marketed illegally. The FDA sent letters to 21 manufacturers and importers demanding information on whether they illegally marketed more than 40 products without agency approval. Some that […]

FDA warns e-cigarette company selling erectile dysfunction drug in e-liquid

FDA warns e-cigarette company selling erectile dysfunction drug in e-liquid

The Food and Drug Administration issued a warning this week to an e-cigarette company that it says sold vaping e-liquid products containing the active ingredients in erectile dysfunction drugs Cialis and Viagra. The FDA gave China-based HelloCig Electronic Technology Co., Ltd. 15 days to address concerns that some of its products were “unapproved new drugs” being sold in the […]

FDA: Unapproved Ingredients in Many Supplements

FDA: Unapproved Ingredients in Many Supplements

By Alan Mozes HealthDay Reporter FRIDAY, Oct. 12, 2018 (HealthDay News) — U.S. health officials have issued more than 700 warnings during the last decade about the sale of dietary supplements that contain unapproved and potentially dangerous drug ingredients, new research […]

Viagra and vape? FDA warns e-cigarette company selling erectile dysfunction drug in e-liquid

Viagra and vape? FDA warns e-cigarette company selling erectile dysfunction drug in e-liquid

CLOSE Teen vaping is reaching epidemic levels and FDA is considering regulation to curb it. One proposal would be banning flavoring of e-cigarette liquids. USA TODAY Scientists at Johns Hopkins Bloomberg School of Public Health found significant amounts of toxic metals in some e-cigarette heating coils.(Photo: amesy, Getty Images/iStockphoto) The Food and Drug Administration issued […]