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Showing 15 posts of 1442 posts found.

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US Judge rules that a decade of unpublished trial results must be made public

February 27, 2020
Medical Communications, Research and Development FDA, US, clinical trials, pharma

A federal judge in New York’s Southern District has ruled that 10 years of unpublished clinical trial data must now …

News
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First US coronavirus trial launched into Gilead’s remdesivir

February 26, 2020
Research and Development FDA, Gilead, US, coronavirus, pharma

The first US clinical trial investigating a treatment for the COVID-19 coronavirus has been launched by the US National Institute …

News

FDA greenlights first oral, daily, non-statin therapy for lowering LDL-Cholesterol

February 25, 2020
Manufacturing and Production, Sales and Marketing Esperion, FDA, Nexletol, pharma

Esperion’s ATP Citrase Lyase (ACL) inhibitor Nexletol (bempedoic acid) has secured approval from the FDA, it has emerged. It is …

News
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FDA approves first adjuvanted quadrivalent flu vaccine in over-65s

February 24, 2020
Sales and Marketing FDA, flu, influenza, pharma, seqirus

The FDA has just authorised its first adjuvanted quadrivalent influenza vaccine, it has been announced. Seqirus’ Fluad Quadrivalent (influenza vaccine, adjuvanted) …

News

Lundbeck’s Vyepti secures US approval for migraine prevention

February 24, 2020
Sales and Marketing FDA, Lundbeck, Vyepti, migraine, pharma

Lundbeck’s Vyepti (eptinezumab-jjmr) has secured approval from the FDA, it has emerged, for the prevention of migraine in adult patients. …

News
fdaoutsideweb

FDA approval for Baudax Bio’s non-opioid painkiller Anjeso

February 24, 2020
Sales and Marketing Anjeso, FDA, opioids, pharma

Baudax Bio has revealed the FDA approval of its non-opioid painkiller Anjeso (meloxicam injection) as a therapy for the management …

News
merckincweb

New Keytruda dosing schedule rejected in six cancers by the FDA

February 20, 2020
Sales and Marketing Cancer, FDA, MSD, keytruda, pharma

MSD’s blockbuster immunotherapy Keytruda has been stopped in its tracks by the FDA after the US regulator rejected its application …

News
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FDA approved over 1,000 generic drugs in 2019

February 20, 2020
Research and Development, Sales and Marketing FDA, generic drugs, pharma

The FDA covered a lot of ground in 2019 when it came to generic drugs, awarding at least tentative approval …

News
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CEO of PixarBio Corporation sentenced to prison for defrauding investors

February 19, 2020
Research and Development Biopharmaceuticals, CEO, FDA, corruption, fraud, investors

Frank Reynolds, the CEO of Boston based PixarBio Corporation, was sentenced to seven years in prison for defrauding investors and …

News
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FDA teams up with Indian government to crack down on illicit drugs shipments

February 19, 2020
Research and Development FDA, FDA India, FDA trade, Indian Pharma

The FDA announced yesterday its first successful bilateral enforcement operation with the Government of India, where they stopped 500 shipments …

News
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Lawsuit against FDA claims Bernie Sanders played role in approval of rival drug

February 17, 2020
Research and Development, Sales and Marketing Bernie, Bernie Sanders, Catalyst Pharmaceuticals, FDA, TRUMP FDA, US FDA

Catalyst Pharmaceutical is attempting to show in court that pressure from US Senator Bernie Sanders led to the approval of …

News
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Eisai withdraws weight loss drug Belviq after FDA highlights cancer risk

February 14, 2020
Medical Communications, Research and Development, Sales and Marketing Belviq, Eisai, FDA, pharma

The FDA has requested that Eisai withdraw its weight loss drug Belviq (lorcaserin) and Belviq XR from the US market …

News
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FDA approves Caption Health’s AI-guided imaging system

February 10, 2020
Sales and Marketing AI, Caption Health, FDA, ultrasound, ultrasound imaging

The FDA have given marketing approval for Caption Health’s Caption Guidance and its use in cardiac ultrasound images.The technology allows …

News
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Seqirus’ Audenz becomes first FDA-approved cell-based adjuvant influenza A vaccine

February 5, 2020
Research and Development, Sales and Marketing FDA, influenza, pharma, seqirus

The FDA has just approved the first adjuvanted, cell-based vaccine for the prevention of influenza A (H5N1) in the US, …

News
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FDA approves first treatment for peanut allergy

February 3, 2020
Sales and Marketing FDA, FDA Peanuts, peanut, peanut allergy, peanut medicine

The FDA has approved its first treatment for peanut allergy in patients between ages four and 17. The drug is …

News
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