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FDA Approvals - FDA chief: Cuts threaten drug approvals Lorraine McCartin s breast cancer
1 Apr 2013
FDA chief: Cuts threaten drug approvals Lorraine McCartin s breast cancer has been in remission for more than a year, thanks to a drug called Kadcyla that the Food and Drug Administration only recently approved solely for patients with late-stage breast cancer. In 2010, McCartin, 56, of Hanson was able to get access to the drug only by flying to Virginia every three weeks as part of a clinical trial, an expense a friend who also had ... Biotech...
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FDA approves Lymphoseek to help locate lymph nodes in patients
31 Mar 2013
FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes....
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FDA approves Osphena for postmenopausal women experiencing pain during sex
31 Mar 2013
FDA approves Osphena for postmenopausal women experiencing pain during sex The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause....
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Titan Pharma: FDA Panel Live Blog Titan Pharma FDA Panel
31 Mar 2013
Titan Pharma: FDA Panel Live Blog Titan Pharma FDA Panel Live Blog BETHESDA, Md. (TheStreet) -- An FDA advisory panel will spend Thursday reviewing a long-acting treatment for opioid addiction from Titan Pharmaceuticals . The panel is expected to be contentious because FDA 's own reviewers expressed doubts about the ability of Titan's drug, known as Probuphine, to adequately curb addiction. The FDA 's concerns, made public in a ... Quidel and Life Technologies Receive FDA Clearance for Clostridium...
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FDA Approvals - FDA Approves Novartis' TOBI Podhaler Novartis AG's TOBI Podhaler (tobramycin
31 Mar 2013
FDA Approves Novartis' TOBI Podhaler Novartis AG's TOBI Podhaler (tobramycin inhalation powder) recently received US FDA approval for the treatment of bacterial lung infection in cystic fibrosis patients caused by the Pseudomonas aeruginosa ... FDA chief: Cuts threaten drug approvals Lorraine McCartin s breast cancer has been in remission for more than a year, thanks to a drug called Kadcyla that the Food and Drug Administration only recently approved solely for patients with late-stage breast cancer. In 2010, McCartin,...