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Endo Pharmaceuticals and Vernalis announced that the FDA has informed the companies it will require an additional three months to review the previously submitted supplemental new drug application (sNDA) for Frova 2.5-mg tablets for the short-term prevention of menstrual migraine.
Immatics has reported that the European Medicines Agency has granted orphan drug status to IMA901, the company's product candidate for the treatment of renal cell cancer.
Advanced Life Sciences has announced that the FDA granted orphan drug designation to cethromycin for the prophylactic treatment of exposure to inhalation anthrax.
Hollis-Eden Pharmaceuticals announced it has decided to end development of its preclinical drug candidate for treating acute radiation syndrome (ARS), Neumune, after meeting with HHS to discuss the agency's decision to exclude Neumune from a solicitation for potential ARS treatments and to cancel the solicitation in its entirety.
Intercell and Statens Serum Institut (SSI) have announced that their collaborative novel tuberculosis (TB) vaccine has been shown to be safe and very immunogenic in healthy individuals in a Phase I clinical trial.
Join FDAnews Monday, March 19, for "Foreign Corrupt Practices Act: Proven Compliance Strategies." In this 90-minute interactive audioconference, Gary Giampetruzzi, senior corporate counsel and deputy compliance officer at Pfizer, will provide guidance on where Foreign Corrupt Practices Act investigations begin and end. On March 20, join RxTrials Institute and FDAnews for "Clinical Trial Quality Assurance: Defining the Gold Standard." In this 90-minute audioconference with Q&A session, Martie Griffin, RN, will provide guidance on the critical activities relating to designing and implementing a gold standard quality assurance program.