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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
BioCryst said it will start shipping its influenza drug Rapivab this week following FDA approval of the first new antiviral flu therapy in 15 years. Read More
The FDA approved Bristol-Myers Squibb’s melanoma treatment Opdivo through its breakthrough therapy pathway, the latest effort by the agency over the past three years to spur development of skin cancer drugs. Read More
The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Zerbaxa to treat complicated intra-abdominal infections and urinary tract infections, the latest approval granted through an initiative to encourage antibiotic development. Read More
Apotex’s application for a biosimilar version of Amgen’s chemotherapy Neulasta has been accepted by the FDA, one of several recent signs that regulatory movement on approving the therapies is gaining momentum. Read More
The FDA has approved AbbVie’s hepatitis C drug Viekira Pak under a breakthrough therapy designation, marking the fourth drug authorized in the past year to treat the chronic liver infection. Read More
A European Medicines Agency advisory panel has recommended approval of Orexigen’s weight-loss drug Mysimba, alongside diet and exercise in overweight or obese adults. Read More