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FDA

Showing 15 posts of 1442 posts found.

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FDA approves Gilead’s blood cancer drug

July 24, 2014
Research and Development, Sales and Marketing Cancer, FDA, Gilead, blood, follicular lymphoma and small lymphocytic lymphoma, lymphocytic leukaemia, sovaldi, zydelig

The Food and Drug Administration has approved Gilead Sciences new treatment Zydelig (idelalisib) to treat three types of blood cancer.  …

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Sun Pharma image

Sun Pharma recalls 40,000 bottles

July 14, 2014
Manufacturing and Production Caraco Pharmaceutical Laboratories, FDA, Pfizer/Wyeth’s Effexor XR, Sun Pharma, antidepressant, recall

India-based manufacturer Sun Pharmaceutical Industries is recalling more than 40,000 bottles of its antidepressant venlafaxine hydrochloride, the US regulator has …

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BMS image

BMS to make Opdivo submission

July 11, 2014
Sales and Marketing BMS, Cancer, EMA, FDA, ono, opdivo, pd-1

Bristol-Myers Squibb is to submit cancer treatment Opdivo to the US authorities after the drug received its first approval in …

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GSK image

GSK manufacturing woes continue

July 8, 2014
Manufacturing and Production Canada, FDA, GSK, Paxil, Vaccine, manufacturing

Health Canada has told GlaxoSmithKline that it wants to see the firm fix major problems at the country’s only flu …

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FDA image

Spectrum wins FDA approval for rare cancer drug

July 4, 2014
Research and Development, Sales and Marketing Beleodaq, Cancer, FDA, Spectrum, non-Hodgkin lymphoma

In an expedited review the FDA has approved a new cancer drug from Spectrum Pharmaceuticals to treat a rare cancer …

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st jude image

FDA clears St. Jude Medical

July 4, 2014
Manufacturing and Production, Sales and Marketing CardioMEMS, FDA, california, st jude medical

US medical device manufacturer St. Jude Medical has been given a clean bill of health by the Food and Drug …

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Amgen image

FDA breakthrough for Amgen

July 2, 2014
Research and Development, Sales and Marketing Amgen, BiTE antibody blinatumomab, FDA, all, leukaemia

Amgen has taken a major step down the road to getting its investigational cancer drug blinatumomab onto the market after …

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Affreza image

FDA ‘yes’ to inhaled insulin

June 30, 2014
Manufacturing and Production, Sales and Marketing Afrezza, FDA, Mannkind, diabetes, insulin human

The FDA has approved the first ‘ultra-rapid-acting’ mealtime insulin therapy available in the US, to improve glycemic control in both …

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astrazeneca image

FDA rejects olaparib

June 27, 2014
Sales and Marketing AstraZeneca, Cancer, FDA, PARP, adp, olaparib

AstraZeneca has been dealt a blow by a key advisory committee to the US Food and Drug Administration, which has …

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Ranbaxy’s Diovan copycat approved in US

June 27, 2014
Manufacturing and Production, Sales and Marketing Diovan, FDA, Novartis, Ranbaxy, blood pressure, sun pharmaceuticals, valsartan

Ranbaxy has won approval for its copycat form of Novartis’ blockbuster blood pressure drug Diovan, as the Swiss firm finally …

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GSK image

FDA warns GSK plant

June 26, 2014
Manufacturing and Production, Sales and Marketing FDA, GSK, Quebec, flu, flulaval, vaccines

GlaxoSmithKline’s Canadian operation has incurred the displeasure of the US Food and Drug Administration for irregularities in its production of …

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India ‘likely’ to increase price caps

June 25, 2014
Manufacturing and Production, Sales and Marketing China, FDA, India, UK, pricing

India’s government is ‘likely’ to increase the number of drugs which are subject to price caps, according to a report …

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AstraZeneca faces olaparib questions

June 24, 2014
Manufacturing and Production, Research and Development, Sales and Marketing AstraZeneca, Cancer, FDA, olaparib, ovarian

AstraZeneca is facing questions from US regulators over the efficacy of one of its most promising late-stage treatments. Olaparib is …

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Lilly’s Efient tipped for expanded NICE approval

June 20, 2014
Sales and Marketing Effient, Efient, FDA, NHS, blood, lilly, longston, thinner

 Eli Lilly’s anti-platelet drug Efient has been given the nod by UK healthcare watchdog NICE for more widespread use, pending …

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FDA publishes ‘new thinking’ on social media use

June 18, 2014
Medical Communications, Sales and Marketing ABPI, FDA, Facebook, Twitter, social media

The FDA has issued new draft guidance on how pharmaceutical and medical device firms in the US can talk about …

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