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Showing 15 posts of 1444 posts found.

FDA slams brakes on trial for world’s most expensive drug following safety concerns in children

October 30, 2019
Research and Development FDA, Novartis, Zolgensma, pharma

The FDA has temporarily shut down a clinical trial evaluating Zolgensma – the world’s most expensive drug at $3.1 million …

News
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FDA approves Vertex’s Trikafta in new indication, now potentially covering 90% of cystic fibrosis patients

October 23, 2019
Research and Development, Sales and Marketing FDA, Trikafta, Vertex, cystic fibrosis, pharma

The FDA has granted marketing authorisation to Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF), it …

News
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Porton Biopharma signs potential $24m deal to push its intranasal anthrax vaccine into Phase 1 trials

October 22, 2019
Manufacturing and Production, Research and Development FDA, Porton Biopharma, anthrax, pharma

Porton Biopharma has signed a modification to its existing agreement with the US National Institute of Health’s National Institute of …

News
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FDA approves Alexion’s Ultomiris in atypical haemolytic uremic syndrome for adults and children

October 21, 2019
Sales and Marketing Alexion, FDA, Ultomiris, pharma, rare disease

The FDA has moved to expand the existing label for Alexion’s Ultomiris (ravulizumab-cwvz) to include the treatment of atypical haemolytic …

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2019 saw the FDA approve more generic drugs than ever before

October 18, 2019
Medical Communications, Sales and Marketing FDA, US, generic drugs, pharma

Fiscal year 2019 was a record-breaking one, according to the FDA. The US regulator smashed its previous total for annual …

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FDA greenlights Genentech’s Xofluza for acute, uncomplicated influenza

October 18, 2019
Medical Communications FDA, Genetech, Roche, US, Xofluza, flu, pharma

Roche subsidiary Genentech has announced that its polymerase acidic endonuclease inhibitor Xofluza (baloxavir marboxil) has been awarded FDA approval in …

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FDA approves first and only transdermal patch for schizophrenia

October 16, 2019
Research and Development, Sales and Marketing FDA, Noven Pharma, Secuado, US, pharma, schizophrenia

Hisamitsu Pharmaceutical subsidiary Noven Pharmaceuticals has revealed the FDA approval of Secuado (asenapine) in adult schizophrenia patients, making it the …

News

Lilly’s Reyvow becomes first FDA-approved 5-HT1F receptor agonist for acute migraine

October 15, 2019
Manufacturing and Production, Sales and Marketing Eli Lilly, FDA, Reyvow, US, migraine, pharma

Eli Lilly has announced that the FDA has given the green light to Reyvow (lasmiditan) in the acute treatment of …

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FDA approves Janssen’s Xarelto for blood clot prevention

October 15, 2019
Manufacturing and Production, Sales and Marketing FDA, Janssen, US, Xarelto, pharma, thromboembolism

Janssen’s Xarelto (rivaroxaban) has secured FDA approval for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalised acutely …

News

FDA approves Pfenex’s osteoarthritis drug for patients at high risk of fracture

October 9, 2019
Research and Development, Sales and Marketing FDA, Pfenex, osteoporosis, pharma

The FDA has awarded US approval to Pfenex’s drug PF708, it has emerged, as a treatment for osteoporosis in certain …

News
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FDA approves Novartis’ Beovu injection for wet age-related macular degeneration

October 8, 2019
Manufacturing and Production, Sales and Marketing Beovu, Eylea, FDA, Novartis, Regeneron, pharma

Novartis has secured FDA approval for its Beovu (brolucizumab) injection in the treatment of wet age-related macular degeneration (AMD), it …

News
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FDA approves single-use auto-injector form of IL-5 inhibitor Fasenra

October 4, 2019
Medical Communications, Sales and Marketing AstraZeneca, FDA, Fasenra, pharma

AstraZeneca is celebrating as the FDA announced the approval of its IL-5 inhibitor Fasenra  (benralizumab) in a pre-filled, single-use auto-injector …

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AbbVie’s Mavyret scores FDA label expansion to shorten treatment duration for hepatitis C patients

September 27, 2019
Medical Communications, Sales and Marketing AbbVie, FDA, hepatitis, hepatitis C, mavyret, pharma

The FDA has chosen to expand the existing label for AbbVie’s Mavyret (glecaprevir/pibrentasvir), it has been revealed, to include the …

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FDA approves Genmab’s Darzalex combo in newly diagnosed multiple myeloma

September 27, 2019
Medical Communications, Sales and Marketing FDA, Genmab, darzalex, pharma

Genmab’s CD38 inhibitor Darzalex (daratumumab) has been awarded marketing authorisation from the FDA in combination with bortezomib, thalidomide and dexamethasone …

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FDA expands Janssen’s Erleada label to cover metastatic castration-sensitive prostate cancer

September 19, 2019
Sales and Marketing Cancer, Erleada, FDA, Janssen, pharma, prostate cancer

Janssen has announced that the FDA has expanded the label of its androgen receptor inhibitor Erleada (apalutamide) to include the …

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