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Sun Pharmaceuticals has initiated a recall of more than 30,000 bottles of bupropion hydrochloride extended-release tablets for the treatment of major depressive disorder and seasonal affective disorder. Read More
A pharmaceutical company in Beijing has received a warning letter from the FDA after barring investigators from the facility as well as falsifying and back-dating records. Read More
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use is recommending the approval of five new medicines and three generics to treat a range of illnesses from cancer to HIV. Read More
India is giving drugmakers of unapproved combination products more time to justify their manufacturing and marketing of the drug in the country. Read More
The International Council for Harmonization has identified the key scientific issues pediatric drug developers must address early on to improve the prospects for a drug’s approval later in the development process, in a draft that updates a 16-year-old efficacy guideline. Read More
NHS England and the UK’s National Institute for Health and Care Excellence have unveiled a proposal for an abbreviated review process for therapies identified as having exceptional value based on cost and effectiveness. Read More
The European Medicines Agency has begun publishing clinical study data for all new drug applications submitted after Jan. 1, 2015, regardless of approval status. Read More