We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA cleared GlaxoSmithKline's (GSK) nasal spray Veramyst April 27 for the "treatment of symptoms of seasonal and perennial rhinitis in adults and children 2 years of age and older." Read More
FDA has barred all approvals for generic versions of Pfizer's Norvasc except for one issued earlier to Mylan, the agency announced in a notice to the U.S. District Court for the District of Columbia. Read More
GlaxoSmithKline (GSK) is anticipating a second-quarter 2007 launch of Flonase follow-on Veramyst, pending FDA approval, the company said during its first-quarter earnings call. Read More
The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products. Read More
GlaxoSmithKline (GSK) is anticipating a second quarter 2007 launch of Flonase follow-on Veramyst pending FDA approval, the company said during its first-quarter earnings call. Read More
Wyeth received an approvable letter from the FDA for its postmenopausal osteoporosis prevention product, bazedoxifene, April 24. Bazedoxifene's brand name, Viviant, is still under FDA review. Read More
Roche's pending applications for investigational erythropoiesis-stimulating agent (ESA) Mircera in the U.S. and Europe are proceeding according to plan, William Burns, CEO of Roche's pharma division, said. Read More