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The FDA approved Asklepion Pharmaceuticals’ Cholbam, the first treatment for children and adults with single-enzyme bile acid disorders and peroxisomal disorders, under its pediatric rare disease priority review voucher program. Under the terms Congress set for the program, the FDA must now phase it out within 12 months unless it is reauthorized. 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
The FDA March 6 gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
The House yesterday passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule. Read More
The European Medicines Agency Tuesday approved Novartis’ Jakavi for patients with polycythemia vera — a rare blood cancer — who cannot take hydroxyurea. Read More
Takeda’s monoclonal antibody Entyvio got a tentative green light from the UK’s health cost watchdog as a treatment for severe colitis, paving the way for a final consultation and adoption by the National Health Service. Read More
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