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Showing 15 posts of 1442 posts found.

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FDA greenlights Lilly’s Olumiant in rheumatoid arthritis, with major caveats

June 5, 2018
Manufacturing and Production, Sales and Marketing Eli Lilly, FDA, Olumiant, pharma

Eli Lilly has announced that its oral JAK inhibitor Olumiant (baricitinib) has received FDA approval for the treatment of moderately-to-severely …

News
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FDA links intragastric balloons to 5 more deaths, bringing total to 12 since 2016

June 5, 2018
Manufacturing and Production, Sales and Marketing FDA, gastric balloon, pharma

Five more deaths have been reported to the FDA in patients using intragastric balloon systems, meaning that 12 total deaths …

News
fda2outsideweb

Kitov’s combo gets FDA approval in osteoarthritis and hypertension

June 1, 2018
Medical Communications, Sales and Marketing Consensi, FDA, Kitov, US, hypertension, osteoarthritis, pharma

Israeli biopharmaceutical firm is celebrating the approval in the US of Consensi, a combo of the calcium channel blocker amlodipine …

News

Pfizer’s Xeljanz becomes first JAK inhibitor approved in US for active ulcerative colitis

May 31, 2018
Sales and Marketing FDA, Pfizer, US, Xeljanz, pharma, ulcerative colitis

Pfizer has revealed that its Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has received FDA approval for the treatment of adult …

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FDA approval for TherapeuticsMD, one year after initial rejection

May 30, 2018
Sales and Marketing FDA, TherapeuticsMD, biotech, drugs, pharma, pharmaceutical

TherapeuticsMD has succeeded in changing the FDA’s mind on its Imvexxy product, after an initial rejection in May of last …

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allergan

Allergan recalls 170,000 birth control packs in US over pregnancy fears

May 30, 2018
Research and Development Allergan, FDA, Taytulla, US, birth control, pharma

Allergan has issued a voluntary recall of its birth control medication in the US marketplace after an error in packaging …

News

UCB’s Cimzia secures first-of-its-kind FDA approval in plaque psoriasis

May 29, 2018
Manufacturing and Production, Sales and Marketing Cimzia, FDA, UCB, US, pharma, psoriasis

The FDA has expanded the label for UCB’s Cimzia (certolizumab pegol) in the US, approving the therapy for the treatment …

News
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FDA cracks down on benzocaine teething products

May 24, 2018
Sales and Marketing FDA, benzocaine, pharma, teething products

The FDA has put its foot down on over-the-counter teething products for infants and children which contain benzocaine, a pain …

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fda2outsideweb

Sun Pharma drug combo scores FDA approval in advanced castration-resistant prostate cancer

May 23, 2018
Research and Development, Sales and Marketing Cancer, Churchill Pharmaceuticals, FDA, Sun Pharma, US, Yonsa, pharma, prostate cancer

Sun Pharma is celebrating with the announcement that its CYP17 inhibitor Yonsa (abiraterone acetate) has been awarded FDA approval in …

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FDA reprimands suppliers of opioid substitute kratom products

May 23, 2018
Research and Development, Sales and Marketing FDA, kratom, opioid crisis, opioids, pharma

The ongoing opioid epidemic in the US has seen the rise of the sale and use of kratom (mitragyna speciose), …

News
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FDA approves AZ’s Lokelma for hyperkalaemia

May 21, 2018
Sales and Marketing AstraZeneca, FDA, Lokelma, hyperkalaemia, pharma

The FDA has revealed its decision to approve AstraZeneca’s oral potassium-removing agent Lokelma (sodium zirconium cyclosilicate) for the treatment of …

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

May 18, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cancer, FDA, Novartis, Takeda, Trump, brexit, pharma, pharmafile, top ten

The year is flying by – it’s another Friday, and that means another Top Ten run-down.Perhaps the biggest story this …

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Pfizer’s Lyrica achieves endpoint as adjunct in paediatric epilepsy

May 18, 2018
Medical Communications, Research and Development FDA, Lyrica, Pfizer, epilepsy, pharma

Pfizer has revealed new Phase 3 data for its oral epilepsy therapy Lyrica (pregbalin) as an adjunctive treatment for partial …

News
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FDA green lights first non-opioid therapy to manage symptoms of opioid withdrawal

May 17, 2018
Sales and Marketing FDA, Lucemyra, opioid crisis, opioids, pharma

As the opioid epidemic continues to grip the US as the leading cause of deaths in those under the age …

News
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FDA issues warning letter over potential for poisoning at India plant

May 15, 2018
Manufacturing and Production FDA, India, biotech, drugs, pharma, pharmaceutical

The FDA has noted a number of failings at a plant in Gujarat, India, but mostly significantly was the finding …

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