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The FDA approved an under-the-tongue formulation of Actavis’ atypical antipsychotic Saphris for 10- to 17-year-old children with bipolar 1 disorder. The company plans to begin marketing the new formulation in the second quarter. Read More
Bristol-Myers Squibb has submitted a new NDA for its hepatitis C drug Daklinza, this time in combination with Gilead Sciences’ Sovaldi for patients with genotype 3 disease. Read More
China’s drug approval backlog ballooned to nearly 18,600 applications by the end of 2014, up more than 30 percent from December 2013, with generics applications representing most of the increase. Read More
The FDA has approved United Therapeutics’ Unituxin in combination with three other drugs for children with neuroblastoma who have seen at least some response to prior combination therapies. Read More
The FDA Tuesday outlined new deadlines and procedures for the way drugmakers seek and conduct meetings with the agency before and during reviews of new product submissions. Read More
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
Astellas Pharma will launch its antifungal drug Cresemba in the coming months, following FDA approval for adults with invasive aspergillosis and invasive mucormycosis — rare, but serious fungal infections most often seen in patients with compromised immune systems. Read More