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The FDA has tentatively declared that vinpocetine does not classify as dietary ingredient, citing its clinical investigation as a new drug and composition as a synthetic compound. Read More
The FDA issued a 483 to Glades Drugs after an inspection revealed that three adverse event reports were associated with Vitamin D3 supplement capsules. Read More
Destiny Pharma reported positive safety and efficacy results from an NIH-supported clinical trial of exeporfinium chloride, for the prevention of post-surgical staphylococcal infections. Read More
The FDA has extended the review period for Novo Nordisk’s Type 2 diabetes candidate IDegLira, just weeks after the agency delayed its decision on a comparable therapy by Sanofi. Read More
The UK’s price watchdog recommended against the reimbursement of Roche’s Cotellic and Zelboraf for the treatment of BRAF V600 mutation-positive melanoma, citing the expensive list price for the products. Read More
The New York attorney general’s office is conducting an investigation to determine if Mylan engaged in anticompetitive practices when entering contracts to sell its allergy therapy EpiPen to schools. Read More