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Showing 15 posts of 1442 posts found.

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Trump administration takes steps to allow cheaper drug imports from Canada

December 18, 2019
Business Services Big Pharma, FDA, Trump, Trump Administraion, US Pharma

The Trump administration is close to allowing the import of some prescription Canadian drugs into the country.The FDA and the …

News
merck__co

FDA advisory panel back Merck & Co.’s Keytruda treatment for bladder cancer

December 18, 2019
Research and Development FDA, Merck, Merck and Co, NHS, NICE, keytruda

An FDA advisory committee voted 9 to 4 in favour of recommending Merk and Co’s Keytruda (pembrolizumab) for treatment in …

News

FDA approves Pfizer and Astellas Pharma’s prostate cancer drug

December 17, 2019
Manufacturing and Production Astellas Pharma, Cancer, FDA, Pfizer, Xtandi, prostate cancer

The FDA has approved Pfizer and Astellas Pharma’s Xtandi (enzalutamide) to treat patients with a type of prostate cancer. The …

News

FDA U-turns to approve Sarepta’s Vyondys 53 in Duchenne muscular dystrophy

December 13, 2019
Medical Communications, Sales and Marketing FDA, Vyondys 53, pharma, sarepta

The FDA has surprised industry pundits by choosing to approve Sarepta’s Vyondys 53 under an accelerated pathway for the treatment …

News
fdaoutsideweb

Correvio’s atrial fibrillation drug voted down by FDA committee over safety concerns

December 11, 2019
Research and Development, Sales and Marketing Correvio Pharma, FDA, atrial fibrillation, pharma

It has emerged that Correvio Pharma’s anti-arrhythmic therapy Brinavess was shot down by the FDA’s Cardiovascular and Renal Drugs Advisory …

News
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FDA investigating if carcinogen NDMA is in diabetes drug

December 6, 2019
Medical Communications FDA, Health Canada, MDMA, NDMA, carcinogen, diabetes

The FDA is looking into if the diabetes drug metformin has unsafe levels of a cancer-causing chemical. This comes after …

News
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Top Ten most popular articles on Pharmafile.com this week

December 6, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cancer, FDA, NHS, corruption, lung cancer, opiods crisis, opioids

Corruption and bribery feature heavily in the news this week. A recently exposed 1997 email chain shows Dr Richard Sackler, …

News
allergan

Allergan’s ubrogepant doses smash primary endpoints in acute treatment of migraine

December 5, 2019
Research and Development Allergan, FDA, pharma, ubrogepant

New Phase 3 data has been released showing that both 50mg and 100mg doses of Allergan’s ubrogepant met their primary …

News
fdaoutsideweb_18

Trump’s new FDA nominee advances in the Senate

December 4, 2019
Research and Development Big Pharma, FDA, FDA commissioner, Trump, US Pharma

Dr Stephen Hahn, President Donald Trump’s FDA nominee, has advanced his nomination to the full Senate chamber. The vote was …

News
tecentriq

Roche’s Tecentriq combo scores FDA approval in non-small cell lung cancer

December 4, 2019
Research and Development, Sales and Marketing FDA, NSCLC, Roche, pharma, tecentriq

Roche’s immunotherapy Tecentriq (atelizumab) has chalked up another approval from the FDA, this time in combination with the chemotherapy Abraxane …

News
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Reagan-era FDA Commissioner Frank Young dies

December 3, 2019
Manufacturing and Production FDA, FDA commissioner, Frank Young

Frank Young, FDA Commissioner from 1984-1989, died on 24 November. He was 88; his son, Jonathan, said the cause was …

News
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FDA urged to investigate use of unapproved drug on prisoners

December 2, 2019
Sales and Marketing FDA, Opiods, US Opiods, opiod crisis

The Louisiana Department of Public Safety and Corrections (LDPSC) and BioCorRx Inc are alleged to have collaborated in testing an …

News

FDA gives priority review for AstraZeneca’s Imfinzi

November 29, 2019
Medical Communications AstraZeneca, Cancer, FDA, Imfinzi, lung cancer

The FDA has granted a priority review of AstraZeneca’s cancer treatment drug Imfinzi (durvalumab) for treatment of patients with untreated …

News
1911-sickle-cells

FDA approves GBT’s Oxbryta to treat sickle cell disease

November 26, 2019
Manufacturing and Production FDA, FDA Trump, Oxbryta, Sickle cell, sickle cell disease

The FDA announced yesterday that it has approved Global Blood Therapeutics’ marketing application for its haemoglobin polymerisation inhibitor Oxbryta, which …

News
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US lawmakers call for FDA office in Israel

November 26, 2019
Manufacturing and Production FDA, Golan Heights, Israel FDA, Netanyahu, Trump, USA, congress, israel

A bipartisan group of 21 US members of Congress has called for the establishment of an FDA office in Israel, …

News
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