“Melanoma is a life-threatening cancer that can cause devastating impacts to affected individuals, with a significantriskof metastasizing and spreading to other areas in the body,” said Nicole Verdun, M.D., director of the Office of Therapeutic Products in CBER. “Today’s approval reflects th...
FOR IMMEDIATE RELEASE Fully Implanted Device Represents New Treatment Option for Patients Unable to Use CPAPInspire Medical Systems, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Inspire Upper Airway Stimulation (UAS) therapy for use in a subset of patients ...
原文:FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord : Second FDA Approved Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option| FDA[1] For Immediate Release:June 11, 2020 The U.S. Food and Drug Administration today approved Upl...
Today, the FDA announced a request for information on a citizen petition asking the FDA to amend the standard of identity for pasteurized orange juice by lowering the minimum soluble solids content, known as the Brix level. Comments are due by October 1...
"Today’s FDA approval marks an exciting day for everyone touched by MS and everyone that has worked on the development of Briumvi. We believe in the importance of treatment alternatives for patients and believe the profile of Briumvi offers unique attributes to patients and physicians alike...
The drug was first approved to treat ALS in Japan and Korea in 2015. After learning about edaravone's use in Japan, the FDA "rapidly engaged" the manufacturer to apply for approval in the United States, said Eric Bastings, MD, deputy director of the neurology products division in the agenc...
The FDA granted approval of Kymriah to Novartis Pharmaceuticals Corp. The FDA granted the expanded approval of Actemra to Genentech Inc. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of...
FDA Advisory Committee Recommends Approval of Takeda's Investigational Biologic Vedolizumab Deerfield, Ill., December 9, 2013 and Osaka, Japan, December 10, 2013 -- Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announ...
The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstratesThe FDA today granted approval for Glatopa, the first generic version of Copaxone 20 mg, according to a press release. “Sandoz, to...
and today’s news for the TOPAZ-1 trial underscores the urgency to deliver new, effective therapies in this setting,” saidSusan Galbraith, executive vice president, oncology R&D of AstraZeneca, in a press release when the FDA accepted thebiologics license application for ...