FDA

Showing 15 posts of 1442 posts found.

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FDA-approved drug could be used to treat Ebola, study shows

August 12, 2019
Sales and Marketing Ebolas, FDA, Romark, nitazoxanide, pharma, virus

The FDA-approved anti-parasitic drug nitazoxanide could be used as a treatment for Ebola, according to researchers from the Boston Children’s …

Senators call on FDA to use “forceful response” against Novartis over faulty data scandal

August 12, 2019
Sales and Marketing AveXis, Bernie Sanders, Elizabeth Warren, FDA, Novartis, Zolgensma

Five senators, including presidential candidates Bernie Sanders and Elizabeth Warren, have condemned Novartis for using “falsified data… to obtain approval …

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Novartis hid faulty data from FDA over $2.1 million gene therapy Zolgensma

August 7, 2019
Research and Development AveXis, FDA, Novartis, Zolgensma, gene therapy, pharma

Novartis hid faulty data from the FDA until their drug was approved, according to a statement from Dr Peter Marks, …

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Daiichi Sankyo’s Turalio becomes first FDA-approved therapy for rare tumour

August 5, 2019
Sales and Marketing Cancer, Daiichi Sankyo, FDA, Turalio, US, pharma, rare cancer

Daiichi Sankyo has seen its CSF1R inhibitor Turalio (pexidartinib) approved by the FDA in the treatment of symptomatic tenosynovial giant …

FDA steps up 2018 drug approvals by 11% on previous year

August 1, 2019
Sales and Marketing EMA, FDA, drug approvals, pharma

The FDA continues to excel in the ground it covers as it emerges that the total number of new drug …

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FDA issues warning to CBD company Curaleaf

July 29, 2019
Sales and Marketing CBD, FDA, cannabidiol, curaleaf, pharma, regulation

The FDA has issued a warning to Massachusetts-based CBD company Curaleaf over the firm’s use of unsubstantiated claims about the …

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Top Ten most popular articles on Pharmafile.com this week

July 26, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Biohaven, FDA, Lyrica, NICE, Pfizer, UK, US, pharma, top ten

At the end of a week that could certainly be called “eventful” here in the UK – one that saw …

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Lilly’s Baqsimi nasal powder gains FDA approval after proving non-inferior to injection

July 25, 2019
Sales and Marketing Baqsimi, Eli Lilly, FDA, US, diabetes, pharma

Eli Lilly has been awarded approval from the FDA for its Baqsimi nasal powder in the treatment of severe hypoglycaemia, …

Elizabeth Warren calls on Albert Bourla to reveal detail of appointment of former FDA commissioner Scott Gottlieb to Pfizer’s board

July 25, 2019
Business Services, Medical Communications Albert Bourla, Elizabeth Warren, FDA, Pfizer, Scott Gottlieb, pharma

Elizabeth Warren has called on Pfizer to reveal the details of Scott Gottlieb’s appointment to the company’s Board of Directors.

fda2outsideweb

FDA approves Pfizer’s biosimilar version of Genentech’s Rituxan

July 24, 2019
Research and Development FDA, Pfizer, Rituxan, Ruxience, biosimilars, pharma

Pfizer has seen Ruxience, its biosimilar version of Genentech’s Rituxan (rituximab), approved by the FDA in the treatment of non-Hodgkin …

FDA approves nine generic versions of Pfizer’s Lyrica

July 23, 2019
Manufacturing and Production, Sales and Marketing FDA, Lyrica, Pfizer, pharma

The FDA has given its approval to the first generic versions of Pfizer’s Lyrica (pregabalin), it has emerged, giving the …

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FDA knocks back Biohaven’s ALS drug over manufacturing concerns

July 22, 2019
Sales and Marketing Biohaven, FDA, Nurtec, amyotrophic lateral sclerosis, pharma

Biohaven Pharmaceutical has seen its new therapy formulation for the treatment of amyotrophic lateral sclerosis (ALS) rejected by the FDA, …

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

July 19, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AMAL Therapeutics, Alzheimer's Ebola, Amgen, AstraZeneca, EMA, FDA, Novartis, pharma

On 12 July news broke that Novartis, Amgen and Banner’s Alzheimer’s Institute were discontinuing a trial into investigational compound CNP520 …

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FDA approves MSD’s combo therapy Recarbrio for urinary tract and intra-abdominal infections

July 18, 2019
Sales and Marketing FDA, MSD, Recarbrio, US, pharma, urinary tract

MSD has announced the approval from the FDA of its combination therapy Recarbrio (imipenem, cilastatin and relebactam) in the treatment …

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