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The National Institutes of Health published a summary of the 240 comments received on a rule mandating that researchers post the results of their clinical trials on a public website. Read More
The Senate Finance Committee and West Virginia’s attorney general are requesting information on the rebates Mylan paid to Medicaid for its allergy treatment EpiPen, a day ahead of a hearing on the price of the combination product. Read More
Hebei Yuxing Bio-Engineering, a Chinese producer of active pharmaceutical ingredients, received a warning letter from the FDA citing significant cGMP and data integrity issues discovered at its manufacturing plant. Read More
Option Care Enterprises received a warning letter from the FDA due to deficiencies in the production of sterile drugs and infusion products at its facility in Everett, Wash. Read More
Several senators expressed doubts that the FDA should take on the regulation of tens of thousands of laboratory-developed tests currently being used across the country, during a committee hearing on the future of regulation in an age of precision medicine. Read More
A federal judge signed off on a $486 million settlement between Pfizer and the company’s shareholders to end a long-standing class action suit alleging the company misrepresented the cardiovascular risks of its analgesics Celebrex and Bextra. Read More