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FDA

Showing 15 posts of 1442 posts found.

FDA pointedly rejects Intellipharma’s opioid painkiller

September 26, 2017
Manufacturing and Production, Sales and Marketing FDA, Intellipharma, biotech, drugs, pharma, pharmaceutical

The FDA has been very public in its stance that it will look to gain the upper hand in bringing …

News
image_credit_interpol

Pangea X: the largest coordinated operation against counterfeit drugs

September 26, 2017
Manufacturing and Production, Sales and Marketing Europol, FDA, biotech, drugs, interpol, pharma, pharmaceutical

Operation Pangea X represents an anniversary, of sorts – as it stands as the 10th year of operations by Interpol …

News

FDA approves first-ever biosimilar for cancer treatment

September 15, 2017
Medical Communications, Sales and Marketing Amgen, Cancer, FDA, Mvasi, avastin, biosimilar

The FDA has announced the news that it has awarded approval to the first-ever biosimilar for the treatment of cancer …

News

FDA halts trial after first CAR T-associated patient death

September 6, 2017
Research and Development CAR T, CAR-T, Cancer, FDA, cellectis, leukaemia, patient death, pharma, pharmaceutical

French clinical-stage biopharma firm Cellectis has received an order from the FDA to halt its study of CAR T therapy …

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Novo Nordisk settles lawsuit over illegal marketing practices for $58.7 million

September 6, 2017
Research and Development, Sales and Marketing FDA, Novo Nordisk, US, US Justice Department, Victoza, diabetes, pharma, pharmaceutical

Novo Nordisk has resolved a probe by the US Justice Department which accused the Danish drugmaker of illegal marketing activities …

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teva

Teva scores expanded indication for Austedo in tardive dyskinesia

August 31, 2017
Sales and Marketing FDA, Teva, medicine, pharma, pharmaceuticals

Following the FDA’s approval of Teva’s Austedo (deutetrabenazine) in the treatment of chorea associated with Huntington’s disease in April this …

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FDA approves first treatment for the ‘silent killer’

August 30, 2017
Research and Development, Sales and Marketing Chagas disease, FDA, biotech, drugs, pharma, pharmaceutical

The FDA has announced that it has granted an accelerated approval for the use of benznidazole in children between the ages …

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FDA fast-tracks recreational drug MDMA for treatment of PTSD

August 30, 2017
Research and Development, Sales and Marketing FDA, MDMA, PTSD, life sciences, pharma, pharmaceuticals

In another leap forward for the promising treatment, the FDA has announced that it has granted Breakthrough Therapy Designation to …

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manufacturing_image_1

‘Trade secret information’ to be shared between EMA and FDA

August 25, 2017
Manufacturing and Production, Medical Communications EMA, FDA, biotech, drugs, pharma, pharmaceutical

As part of the on-going harmonisation of manufacturing standards across the Atlantic, the EMA and FDA have announced that they …

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FDA approves Ironwood’s combination gout treatment

August 22, 2017
Manufacturing and Production, Sales and Marketing Duzallo, FDA, Ironwood Pharmaceuticals, gout, life sciences, pharma, pharmaceuticals

Ironwood Pharmaceuticals has announced that the FDA has approved its drug Duzallo for the treatment of hyperuricemia associated with gout …

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Pfizer’s leukaemia drug gets opposing regulatory decisions on either side of the Atlantic

August 18, 2017
Medical Communications, Sales and Marketing Besponsa, Cancer, FDA, NICE, Pfizer, leukaemia, pharma, pharmaceutical

Pfizer has received a bittersweet bout of news as it emerges that its drug Besponsa (inotuzumab ozogamicin) has received approval …

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FDA recalls liquid pharma products after bacterial contamination detected

August 17, 2017
Medical Communications, Sales and Marketing FDA, life sciences, pharma, pharmaceutical

The FDA has announced that it has been forced to recall a range of liquid pharmaceutical and dietary supplement products …

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Top Ten most popular articles on Pharmafile.com this week

August 11, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Merck, NICE, Parkinson's, biotech, diabetes, pharma, pharmaceutical, top ten

Another week, another busy week in pharma. The last seven days have seen some remarkable strides in the diabetes space, …

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FDA awards orphan status to new brain cancer vaccine

August 9, 2017
Research and Development, Sales and Marketing FDA, life sciences, orphan drug, pharma, pharmaceuticals

The FDA has announced that it has awarded orphan drug status to the vaccine SurVaxM for patients with glioblastoma, the …

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FDA turns down Janssen’s sirukumab for rheumatoid arthritis

August 3, 2017
Sales and Marketing FDA, Janssen, drugs, life sciences, medicine, pharma, pharmaceuticals, rheumatoid arthritis, sirukumab

Janssen has announced that it has suffered a knockback to its plans to commercialise sirukumab in the US in the …

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