Insmed Announces FDA Clearance Of IND For Pivotal Phase 3 Trial Of ARIKACE In Nontuberculous Mycobacteria Indication
Insmed Incorporated (Nasdaq: INSMD), a biopharmaceutical company, announced that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of ARIKACE (liposomal amikacin for inhalation) in nontuberculous mycobacteria (NTM) lung infections has been cleared by the U.S. Food and Drug Administration (FDA). In 2010, Insmed initially submitted a regulatory ...

Brain Tumor Blasting Device Clears First Hurdle With FDA - Seattle Patient Advocate Applauds Vote As "Victory For ...
Calling it "a great day for brain cancer patients," national patient advocate, Dellann Elliott, president and CEO of the Seattle-based Chris Elliott Fund, applauded a Food and Drug Administration (FDA) panel s vote to back a new brain tumor-blasting device called NovoTTF. Elliott testified before the Neurological Devices Panel of the Medical Devices Advisory Committee to the FDA on Thurs ...