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Showing 15 posts of 1442 posts found.

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Bayer’s Gadavist becomes first FDA-approved drug for MRI in coronary artery disease patients

July 16, 2019
Manufacturing and Production, Sales and Marketing Bayer, FDA, Gadavist, coronary artery disease, pharma

The FDA has awarded approval to Bayer’s Gadavist (gadobutrol) injection, the company confirmed.

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FDA and EMA fully implement mutual recognition agreement between US and EU

July 15, 2019
Sales and Marketing EMA, FDA, GMP, Slovakia, mra, mutual recognition, pharma

The FDA has recognised Slovakia’s ability to carry out inspections of manufacturing facilties. The recognition of Slovakia marks the full …

News
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AstraZeneca’s Farxiga fails to get FDA approval for patients with Type 1 diabetes

July 15, 2019
Sales and Marketing AstraZeneca, EMA, FDA, US, diabetes, farxiga

The FDA had said it will not approve AstraZeneca’s diabetes drug Farxiga for use as a supplement to insulin in …

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FDA sharpen focus on pharmaceutical companies under Trump

July 5, 2019
Medical Communications FDA, Obama, Trump, USA, pharma, regulation

The overall number of warning letters being sent out by the FDA has dropped under President Donald Trump, according to …

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FDA approves multiple myeloma therapy Xpovio despite safety concerns

July 4, 2019
Sales and Marketing FDA, Karyopharm, Xpovio, multiple myeloma, pharma

The FDA has made the controversial decision to approve the nuclear export inhibitor Xpovio (selinexor) from Karyopharm Therapeutics, in combination …

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Elizabeth Warren calls on former FDA commissioner Scott Gottlieb to resign from board of Pfizer

July 2, 2019
Research and Development FDA, Pfizer, Scott Gottlieb, health, pharma, public health

Democrat Presidential candidate Elizabeth Warren has criticised Scott Gottlieb for joining Pfizer.   In a letter to Gottlieb, Senator Warren …

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Former FDA Commissioner Scott Gottlieb elected to Pfizer’s Board of Directors

June 28, 2019
Medical Communications FDA, Pfizer, Scott Gottlieb, pharma

Dr Scott Gottlieb, who stepped down from his role as the 23rd Commissioner of the FDA earlier this year, has …

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FDA approves Dupixent for chronic rhinosinusitis with nasal polyposis

June 27, 2019
Sales and Marketing Dupixent, FDA, Sanofi, US, pharma, rhinosinusitis

Regeneron Pharmaceuticals and Sanofi have revealed that their dual IL-4 and IL-13 inhibitor Dupixent (dupilumab) has secured FDA approval in …

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FDA knocks back Glenmark’s allergic rhinitis therapy Ryaltris

June 25, 2019
Manufacturing and Production, Sales and Marketing FDA, Glenmark, Ryaltris, US, allergy, pharma

Stocks in Indian pharmaceutical firm Glenmark were sent plummeting to a six-year low after it was confirmed that the FDA …

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FDA expands Vertex’s cystic fibrosis drug Symdeko in paediatric patients

June 24, 2019
Sales and Marketing FDA, Symdeko, Vertex, cystic fibrosis, pharma

Vertex has announced that the FDA has chosen to expand the existing authorisation on its cystic fibrosis (CF) therapy Symdeko …

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FDA approve libido enhancing drug for women with low sexual desire

June 24, 2019
Sales and Marketing FDA, HSDD, health, pharma, viagra, vyleesi

The FDA has approved a new drug for women with low libido.The FDA has approved AMAG Pharmaceuticals’ bremelanotide – sold …

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Top Ten most popular articles on Pharmafile.com this week

June 21, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, GSK, MSD, Parkinson's, blockchain, brexit, top ten

It’s Friday, and time for another run-down of the week’s most popular articles.

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MSD’s Keytruda snatches up first approval in small cell lung cancer

June 19, 2019
Research and Development, Sales and Marketing Cancer, FDA, MSD, US, keytruda, lung cancer, pharma

MSD has revealed that its anti-PD-1 immunotherapy Keytruda (pembrolizumab) has been awarded marketing authorisation from the FDA as a monotherapy …

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FDA expand Paragraph IV Patent Certifications List for generic drugmakers

June 19, 2019
Research and Development FDA, Hatch-Waxman act, generic drugs, generics, pharma

The FDA has said that it is expanding a database used by generic drugmakers to get information on when their …

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Patient dies after receiving faecal transplant

June 17, 2019
Sales and Marketing Adverse Event, E.Coli. AMR, FDA, faecal transplant, pharma

A person has died after experiencing an adverse event related to a faecal transplant. The FDA has warned that two …

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