FDA says new cholesterol drugs may not need outcome studies
Members of an experimental class of cholesterol-lowering drugs could get U.S. regulatory approval based on their ability to lower “bad” cholesterol, and may not need to show that they reduce the risk...
View ArticleEarly FDA approval for Portola
South San Francisco-based Portola Pharmaceuticals ($PTLA) has nabbed boasting rights to the FDA’s new breakthrough drug designation for andexanet alfa (PRT4445), its Factor Xa inhibitor antidote...
View ArticleNew drug approvals plunge in 2013
The wave of new drug approvals that had been building at the FDA has broken. According to the official tally of new drug and biologics approvals at the agency, the biopharma industry registered only 27...
View ArticleFDA Grants Breakthrough Status to Gene Therapy for First Time
Celladon became the first company to receive breakthrough status for a gene therapy treatment in development. The treatment, MYDICAR, is intended to reduce the risk of heart failure in patients with a...
View ArticleCubist’s superbug drug clears FDA panel
Cubist’s latest antibiotic won praise from a panel of FDA advisers, setting the stage for a likely approval and head-to-head competition with Pfizer’s blockbuster Zyvox. The FDA’s Anti-Infective Drugs...
View ArticleUCSF, Stanford and Johns Hopkins join FDA partnership to speed drug development
At a time when Big Pharma is increasingly tapping academic institutions for expertise in informatics and data-driven computer models for drug discovery, the FDA has selected Johns Hopkins University,...
View ArticleAnalyzing the Winners and Losers in the Growth of Non-oral Patient...
Success of Delivery Device Developers in Solving Formulation Limitations a Key Factor according to Greystone Research Associates (Amherst, NH) – As patients live longer and the prevalence and incidence...
View ArticleSeegene Receives FDA Clearance for its Herpes Simplex Virus Molecular Test
Gaithersburg, Maryland and SEOUL, Korea, February 17, 2015 - Seegene Inc. (096530.KQ), a leading developer of multiplex PCR technologies, today announced that the U.S. Food and Drug Administration...
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