FDA
AbbVie scoops up FDA approval for Rinvoq in moderately to severely active rheumatoid arthritis
August 19, 2019Sales and Marketing AbbVie, FDA, Rinvoq, pharma, rheumatoid arthritis
The FDA has awarded marketing authorisation to AbbVie’s Rinvoq (upadacitinib) for the treatment of moderately to severely active rheumatoid arthritis, …
Pfizer recall two batches of migraine drug Relpax
August 16, 2019Medical Communications FDA, Pfizer, Relpax, migraine, pharma, recall
Pfizer has recalled two lots of its migraine drug Relpax over concerns about microbiological contamination. In a statement on the …
FDA approve new drug for treatment-resistant TB
August 15, 2019Research and Development FDA, TB, US, pharma, pretomanid, tuberculosis
The US FDA has approved BPaL, the TB Alliance’s treatment for drug-resistant tuberculosis (TB). The US regulator gave the go-ahead …
FDA-approved drug could be used to treat Ebola, study shows
August 12, 2019Sales 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, 2019Sales 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 …
Novartis hid faulty data from FDA over $2.1 million gene therapy Zolgensma
August 7, 2019Research 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, …
Daiichi Sankyo’s Turalio becomes first FDA-approved therapy for rare tumour
August 5, 2019Sales 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, 2019Sales 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 …
FDA issues warning to CBD company Curaleaf
July 29, 2019Sales 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 …
Top Ten most popular articles on Pharmafile.com this week
July 26, 2019Business 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 …
Lilly’s Baqsimi nasal powder gains FDA approval after proving non-inferior to injection
July 25, 2019Sales 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, 2019Business 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.
FDA approves Pfizer’s biosimilar version of Genentech’s Rituxan
July 24, 2019Research 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, 2019Manufacturing 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 …
FDA knocks back Biohaven’s ALS drug over manufacturing concerns
July 22, 2019Sales 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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