Tag Archives: US FDA

US FDA approves two hepatitis C drugs for paediatric patients

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.

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Cardiologist warns against dissolvable stents

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.

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Asia poised to become preferred destination for clinical trials: Frost & Sullivan

Sydney: Asia is poised to become the preferred destination for clinical trials, according to a white paper released by Frost & Sullivan.

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US FDA approves Xermelo for carcinoid syndrome diarrhoea

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.

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US FDA approves new psoriasis drug

Washington: The US Food and Drug Administration on Wednesday approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.

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Delhi surgeons perform ‘India’s first’ three level artificial cervical disc replacement surgery

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.

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US FDA approves Trulance for Chronic Idiopathic Constipation

Washington: The US Food and Drug Administration has approved Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients.

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US FDA approves first drug for spinal muscular atrophy

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.

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New tissue expander for women undergoing breast reconstruction following mastectomy

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.

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Device approved to replace fingerstick testing for diabetes treatment decisions

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.

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