FDA

Showing 15 posts of 1442 posts found.

Merck drug shines at ASCO

June 4, 2014
Research and Development, Sales and Marketing ASCO, Cancer, FDA, MK-3475, Merck, melanoma

Merck has shown off one of its investigative cancer drug’s impressive results in advanced head and neck cancer at ASCO …

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Lemtrada resubmitted to FDA

June 2, 2014
Sales and Marketing FDA, Lemtrada, MS, Sanofi

Sanofi has resubmitted its application for Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis (MS) to the …

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BMS and AbbVie get FDA lift

May 21, 2014
Research and Development, Sales and Marketing AbbVie, BMS, FDA, elotuzumab, multiple, myeloma

Bristol-Myers Squibb and AbbVie are celebrating after receiving breakthrough designation status from the US regulator for their investigational medicine elotuzumab …

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‘Star Wars’ robot arm approved by FDA

May 12, 2014
Manufacturing and Production, Medical Communications, Sales and Marketing FDA, arm, deka arm system, luke, star wars

The FDA has approved a first of its kind robotic arm that can be used to make complex tasks far …

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Merck’s vorapaxar gains long-awaited FDA approval

May 9, 2014
Sales and Marketing Boehringer, FDA, Merck, lilly, vorapaxar, zontivity

Merck’s heart drug vorapaxar has finally been given the FDA go-ahead after looking dead in the water less than two …

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Latest Sun Pharma recall blow for firm

May 9, 2014
Manufacturing and Production Caraco, Cetirizine, Effexor, FDA, Sun Pharma, recall

India’s largest drugmaker Sun Pharmaceutical Industries is recalling almost 400,000 bottles of anti-depressant and antihistamine medications in the US, because …

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FDA approves Zykadia for late-stage lung cancer

April 30, 2014
Research and Development, Sales and Marketing Cancer, FDA, Novartis, lung, zykadia

Novartis’ ‘breakthrough’ drug Zykadia has been approved by the FDA to treat lung cancer patients with a particular genetic mutation. …

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GSK bribery controversy spreads to Poland

April 14, 2014
Medical Communications, Sales and Marketing China, FDA, GSK, Witty, bribery, cctv, iraq

Poland has become the latest country in a string of bribery claims to hit GSK as it faces legal action …

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Regulatory woes eclipse Sun Pharma deal

April 10, 2014
Manufacturing and Production, Sales and Marketing FDA, India, Ranbaxy, Sun Pharma

The $4 billion merger between Indian generic firms Sun Pharma and Ranbaxy has been soured by reports that the deal …

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Under fire Ranbaxy sold to Sun Pharma for $4 billion

April 7, 2014
Manufacturing and Production, Sales and Marketing FDA, Ranbaxy, Sun Pharma, deal, hamburg, manufacturing

Sun Pharmaceutical Industries has bought struggling drugmaker Ranbaxy Laboratories in a deal that will see the two companies become the …

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FDA slams GSK for manufacturing oversights

April 3, 2014
Manufacturing and Production FDA, GMP, GSK, Ireland, cork, mage, manufacturing

The FDA has warned GlaxoSmithKline that the US importation of products from the firm’s facility in Cork, Ireland could be …

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Inhaled insulin one step closer to approval

April 3, 2014
Sales and Marketing Afrezza, FDA, Mannkind, diabetes, type 1, type 2

After a rocky few years MannKind’s inhaled insulin Afrezza finally looks to be on the path to approval in the …

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Alli bottles tampered with in US, drug recalled

March 27, 2014
Manufacturing and Production, Sales and Marketing Alli, FDA, GSK, Roche, Xenical, obesity, weight loss

GlaxoSmithKline has admitted that some bottles of its weight-loss drug Alli bought in the US have been tampered with. US …

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FDA unconvinced on Novartis heart drug

March 26, 2014
Research and Development, Sales and Marketing FDA, Novartis, ahf, heart, serelaxin

The prospects of Novartis’ latest heart drug being approved in the US anytime soon appear to have been scuppered by …

Xolair gets FDA approval for skin condition

March 24, 2014
Research and Development, Sales and Marketing FDA, Novartis, Roche, Sanofi, Xolair, chronic hives, csu

 An asthma drug developed by Roche subsidiary Genentech and Novartis has been granted an additional indication to treat chronic hives …

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