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India's Dr Reddy's gets FDA warning letter for three drug plants
2015-11-06 07:48:12| Biotech - Topix.net
MUMBAI: Dr Reddy's Laboratories Ltd, India's second-largest drugmaker by sales, received a warning letter from the U.S. Food and Drug Administration over inadequate quality control procedures at three manufacturing plants in India. Dr Reddy's shares fell as much as 12 percent in early trade to their lowest level since July 30. The warning letter was issued by the FDA to Dr Reddy's on Thursday for its Srikakulam, Miryalaguda and Duvvada drug manufacturing plants - all based in southern India.
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letter
drug
warning
FDA approves Gilead Sciences' HIV drug cocktail
2015-11-05 21:26:44| Biotech - Topix.net
REUTERS: Gilead Sciences Inc said on Thursday the U.S. Food and Drug Administration approved its HIV drug cocktail, Genvoya, to treat infection in adults and patients 12 years of age and older. Genvoya, a combination tablet approved as a complete regimen, aims to treat patients who have never been treated with HIV therapy.
Tags: drug
sciences
hiv
cocktail
FDA approves GSK's drug Nucala for severe asthma
2015-11-05 01:47:14| Biotech - Topix.net
GlaxoSmithKline Plc won U.S. regulatory approval for its drug Nucala to treat severe asthma, the Food and Drug Administration said on Wednesday. The drug, Nucala, known also as mepolizumab, was approved for use in combination with other therapies for patients 12 and older who have a history of severe asthma attacks.
Tyme Technologies, Inc. Receives FDA Acceptance Of Investigational New Drug Application For Oncology Drug Candidate, SM-88
2015-11-03 04:55:30| drugdiscoveryonline News Articles
Tyme Technologies, Inc., a research and development company operating through its wholly-owned subsidiary, Tyme Inc., focused on development and eventual commercialization of oncology products, announced recently that the U.S
Tags: application
drug
technologies
acceptance
FDA Advisory Committee Recommends The Approval Of Lesinurad For Gout Patients
2015-11-03 04:41:07| drugdiscoveryonline Home Page
AstraZeneca recentlyannounced that the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10-4 to recommend the approval of lesinurad 200 mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI)
Tags: committee
approval
patients
advisory
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