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Drugmakers are expected to collect individual cases of suspected adverse reactions linked to off-label use but not individual reports when there has been no associated adverse event, the EMA said in April. Read More
UK regulators have fined Pfizer $14,000 for failing to explain a questionable claim meant to justify price increases on the generic seizure medication Epanutin. Read More
The European Medicines Agency is providing guidance on how drugmakers can best incorporate patient-reported outcomes in developing oncology studies. Read More
Despite grave doubts, an Indian high court judge is allowing two drugmakers to market and produce contested biosimilars of Roche’s breast cancer therapy Herceptin. Read More
An FDA inspection uncovered a host of GMP deficiencies at a Wockhardt production plant in India, despite earlier attempts by the company to downplay the findings. Read More
The EMA’s Committee for Medicinal Products for Human Use is recommending approval for six drugs within the EU and another for export-only from EU countries. Read More
The list of Chinese pharmaceutical companies in the FDA’s crosshairs keeps on growing, with the agency hitting two drugmakers for GMP violations and another for refusing an inspection. Read More
It has been a successful month in the UK for French drug giant Sanofi, with the National Institute for Health and Care Excellence backing two of its drugs. Read More
French authorities want to ban marketing applications from an Indian manufacturing site after an inspection turned up a whopping 58 GMP violations. Read More