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The FDA approved seven new drugs last month, pushing its total to 41 last year, the highest number of new molecular entities cleared by the agency since 1996. Read More
Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco has won FDA approval for an additional indication to treat patients six years and older with at least one copy of the R117H gene mutation. Read More
The FDA approved Hospira’s nonsteroidal anti-inflammatory drug (NSAID) analgesic Dyloject to treat mild to moderate pain as well as moderate to severe pain either on its own or in combination with opioid analgesics. Read More
Genentech bolstered its case that Gazyva is more effective at treating front-line leukemia than the company’s older drug Rituxan, which is set to face stiff biosimilar competition in a few years. Read More
The FDA on Monday published 28 new product-specific guidances and revised testing recommendations on another 15 therapies to aid ANDA filers in designing bioequivalence studies for their applications. Read More
Manufacturers of pandemic flu vaccines will have more leeway in what they submit to the European Medicines Agency, according to final guidance that consolidates the requirements for premarket submissions for all types of influenza vaccines. Read More
Boehringer Ingelheim’s advanced lung cancer drug Vargatef is too expensive to justify the modest benefit it provides patients, according to the UK’s healthcare cost watchdog that recommended against coverage. Read More
European regulators approved Novartis’ eye drop drug Travatan to treat pediatric glaucoma patients, expanding patent protection for the treatment by another six months. Read More
The FDA will maintain its policy on determining when an orphan drug product is entitled to market exclusivity, saying a recent federal court ruling that overruled the agency’s policy applied to just one drug and established no precedent. Read More