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FDA

Showing 15 posts of 1442 posts found.

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AZ and Takeda diabetes drugs get FDA safety update

April 15, 2015
Manufacturing and Production, Sales and Marketing AstraZeneca, FDA, Nesina, Onglyza, Takeda, alogliptin, cardiovascular, diabetes, saxagliptin

An FDA advisory committee has said that the labels of two type 2 diabetes drugs should be changed to warn …

News

Manufacturing woes hit Baxter again

April 14, 2015
Manufacturing and Production, Sales and Marketing FDA, Gemünden, Pfizer, alesse, baxter, manufacturing, recall, vectura group

Baxter is voluntarily recalling several lots of intravenous solutions due to the potential presence of particulate matter.  The news has …

News
Astrazeneca image

AstraZeneca diabetes drug could ‘significantly’ increase mortality

April 13, 2015
Research and Development, Sales and Marketing AstraZeneca, FDA, Nesina, Onglyza, Takeda, alogliptin, cardiovascular, saxagliptin

AstraZeneca’s diabetes drug Onglyza may lead to a ‘significant increase’ in risk of death according to a new analysis from …

News
Phone image

E-clinical: the rise of new health technologies

April 13, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, NHS, apps, digital, eHealth, eyeforpharma, kelsey, pharma, wearables

In the UK the NHS is generally considered to be traditionally resistant to new technology, but it has been forced …

Feature
Shire image

Shire gets FDA boost – but suffers trial setback

April 10, 2015
Research and Development, Sales and Marketing FDA, Shire, algs, lifitegrast, shp625

Shire has achieved mixed results in its attempts to get regulatory approval for two new treatments – bagging a priority …

News
margaret_hamburg

Former FDA commissioner named as Institute of Medicine foreign secretary

April 9, 2015
Manufacturing and Production, Medical Communications, Research and Development Dr Margaret Hamburg, FDA, IOM, Institute of Medicine, Margaret Hamburg

Former commissioner of the US Food and Drug Administration Margaret Hamburg has been appointed as the next foreign secretary of …

Appointment
Gilead image

Gilead’s next-generation HIV drug to be FDA assessed

April 8, 2015
Research and Development, Sales and Marketing F/TAF, FDA, Gilead, HIV, Tenofovir Alafenamide, emtricitabine

Gilead Sciences has filed its second new drug application for a new combination HIV treatment with the FDA.The California-based company …

News
Shire image

Shire plots new ADHD drug approval

April 7, 2015
Sales and Marketing ADHD, FDA, SHP465, Shire, Vyvanse, clinical trials, paediatrics

Shire is launching a new clinical trial as part of its FDA submission for a potential ADHD treatment. The company …

News
Novartis image

Novartis drug to treat iron overload gets US nod

March 31, 2015
Sales and Marketing FDA, Novartis, blood, deferasirox, exjade, iron, jadenu

Novartis’ iron overload drug Jadenu has been given the green light by US regulators to treat patients with a serious …

News

Novartis in major oncology drive

March 30, 2015
Research and Development, Sales and Marketing Cancer, FDA, MHRA, Novartis, aduro, ceritinib, eams, early access, zykadia

Novartis says it is ‘stepping up its efforts’ in cancer by launching major initiatives to discover new treatments to combat …

News
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Novo resubmits FDA application for two diabetes drugs

March 27, 2015
Sales and Marketing Danish, FDA, Novo Nordisk, Ryzodeg, Tresiba, diabetes

Novo Nordisk will re-submit an FDA application for its diabetes drugs Tresiba and Ryzodeg two years after their initial rejection …

News
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Daiichi Sankyo cuts 16% of US staff

March 27, 2015
Sales and Marketing Benicar, Daiichi Sankyo, FDA, Ranbaxy, Welchol, ambit, colesevelam, cuts, olmesartan

Daiichi Sankyo is laying off 16% of its staff at its US commercial headquarters as the company braces itself for …

News
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Bayer and Regeneron eye drug gains another indication

March 26, 2015
Sales and Marketing Bayer, Eylea, FDA, Japan, Lucentis, MRI, Regeneron, aflibercept

Bayer and Regeneron’s Eylea has added to a growing list of indications with its new approval to treat a type …

News
Homeopathy image

FDA to review homeopathy rules

March 25, 2015
Research and Development, Sales and Marketing Australian Government’s National Health and Medical Research Council, FDA, homeopathy

The FDA is to hold a public meeting to “obtain information and comments from stakeholders” on the use of homeopathic …

News
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Novo Nordisk obesity drug gets EU approval

March 24, 2015
Sales and Marketing EMA, EU, FDA, Victoza, liraglutide, obesity, saxenda

Novo Nordisk’s obesity drug Saxenda has been approved by the European Commission for use across the EU. This approval follows …

News
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