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The FDA is requiring new cardiac and cerebral warnings for Genentech’s asthma drug Xolair, based on an evaluation of long-term safety data, but the agency stopped short of mandating the strictest black box warning. Read More
Patients will be invited to participate in scientific discussions on the benefits and risks of certain drugs in Europe, under a new European Medicines Agency pilot project. Read More
Clinical studies to evaluate drugs treating irritable bowel syndrome (IBS) should involve patients experiencing recurrent abdominal pain or discomfort at least three days per month in the previous 90 days, according to new final guidance issued by the European Medicines Agency. Read More
Drugmakers, importers, marketers and distributors in India must report company details, production sources and product lists in an online database by next month, according to the country’s drug regulatory authority. Read More
Pharmaceutical companies developing new pediatric vaccines for diphtheria, tetanus and pertussis (DTaP) should conduct clinical trials using a single dosing schedule as a means to streamline the process, according to a new guidance from the European Medicines Agency. Read More
Drugmakers should develop assays, tests and other processes to identify and mitigate any impurities in their products that may cause cancer, according to a European Medicines Agency guideline set to take effect January 2016. Read More
Canadian regulators plan to ratchet up scrutiny of patent litigation settlements between brand and generic drugmakers in search of antitrust deals that delay generic competition. Read More
A new bipartisan House bill would stop brandmakers from relying on a drug-control program to deny generics firms the batch samples they need to put together an ANDA. Read More
The FDA warned an active pharmaceutical ingredient manufacturer for not paying its facility user fees. However, the company says it hasn’t made APIs since 2008. Read More