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The FDA should speed up its ANDA median approval times so that generics manufacturers with first-filer status don’t lose their 180 days of marketing exclusivity, firms said. Read More
Two FDA advisory panels last week overwhelmingly recommended the agency not approve Clarus Therapeutics’ Rextoro testosterone replacement therapy. Read More
House lawmakers are making a new push to pass stalled legislation that would enable the FDA to accept less clinical data to approve antibiotics, the latest effort from the federal government to combat the spread of drug-resistant infections. Read More
The FDA approved Eli Lilly’s diabetes drug Trulicity as a once-weekly subcutaneous injection to improve blood sugar levels, along with diet and exercise, in adults with the type 2 form of the disease. Read More
The UK’s health-cost watchdog has recommended coverage of GlaxoSmithKline’s melanoma drug Tafinlar, but is requiring GSK to provide a discount on the product. Read More
The UK’s health-cost watchdog has recommended coverage of Janssen hepatitis C drug Olysio, but also has asked for more data proving its effectiveness in certain patient populations. Read More
The UK’s health-cost watchdog said it’s not ready to change the way it appraises medicines and other technologies, but acknowledged that further consideration is needed on how new treatments are developed, evaluated and supported for adoption in the National Health Service (NHS). Read More
AstraZeneca and Nektar Therapeutics say they hope to market their newly approved opioid-induced constipation drug Movantik in early 2015, but the launch date remains uncertain as the Drug Enforcement Administration considers a request to deschedule the product. Read More