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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
Drugmakers can now receive a priority review voucher for a separate product, and redeem it within three months, if they pursue development of Ebola treatments. Read More
AstraZeneca’s first-in-class ovarian cancer drug Lynparza will soon be available in Europe, following European Medicines Agency approval late this week. Read More
The FDA has cleared Alcon Research’s eardrop Xtoro for acute otitis externa infection, marking the agency’s first new approval of a flouroquinolone antibiotic. Read More
Veloxis Pharmaceuticals has filed a lawsuit demanding the FDA grant final approval of its extended-release immunosuppression drug Envarsus, which is being held up by the exclusivity of a rival product. Read More
The FDA has approved 35 novel new drugs so far this year, up from 27 products last year, with officials touting 2014 as the best year ever for rare disease treatment approvals. Read More