Tag Archives: US FDA
Washington: The US Food and Drug Administration on Friday approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults.
Washington: In an editorial published in the New England Journal of Medicine (NEJM), Dr Debabrata Mukherjee provides expert commentary on bioresorbable stents, an alternative to the traditional stents used in patients with cardiac conditions. In his editorial, Dr Mukherjee encourages cardiologists to continue using conventional drug-eluting stents, instead of the newer bioresorbable option.
Sydney: Asia is poised to become the preferred destination for clinical trials, according to a white paper released by Frost & Sullivan.
Washington: The US Food and Drug Administration on Tuesday approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analogue (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhoea that SSA therapy alone has inadequately controlled.
Washington: The US Food and Drug Administration on Wednesday approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.
New Delhi: In a rare and complex surgery of the cervical spine, two leading neurosurgeons of Delhi claimed to have performed, for the first time in India, a three level cervical disc prolapse surgery followed by replacement of the patient’s natural disc with an artificial disc to preserve the patient’s range of movement in the neck. According to the surgeons, this is only the second such surgery reported in Asia.
Washington: The US Food and Drug Administration has approved Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients.
Washington: The US Food and Drug Administration on Friday approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord.
Washington: The US Food and Drug Administration on Wednesday allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities. A patient uses a dose controller to independently inflate the expander.
Washington: The US Food and Drug Administration has expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people two years of age and older with diabetes.