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The Chinese FDA has made sweeping reforms to the country’s nine-year-old drug registration rules, looking for industry feedback on a range of drug approval related revisions. Read More
The Bangladesh High Court has targeted 34 drug firms for ignoring an earlier ban on their products, demanding that they immediately recall their products. Read More
With strong pipelines in Europe, Japan and the U.S., regenerative medicine is poised to become a $68 billion market in the next four years, according to a new report. Read More
The UK’s drug pricing watchdog has backed the reimbursement of five therapies by NHS England, provided the companies offer the drugs at discounted prices. Read More
After nearly two years, the EMA is formalizing its iterative pathway program that saw six applications progress to formal advice from the agency. Read More
EMA is proposing a broader scope for guidelines on initial human trials to address emergent practices and safety issues linked to participant deaths. Read More
Sentara Enterprises has received a letter from the FDA after an inspection of its facility in response to information from the Virginia Department of Health on two cases of illness in pediatric patients who were given Sentara products. Read More
The FDA is citing three pharmaceutical firms for a litany of GMP violations that range from data integrity discrepancies to laboratory control deficiencies. Read More
The FDA has more than a $300 million surplus due to its user fee programs, but has no detailed plan for using the money, according to a health care think tank. Read More
A federal judge has affirmed UCB’s patent for Vimpat, blocking efforts by several drugmakers to market generic versions of the epilepsy drug. Read More