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Showing 15 posts of 1442 posts found.

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FDA expands indication for Eylea to cover all stages of diabetic retinopathy

May 14, 2019
Manufacturing and Production Bayer, Eylea, FDA, Regeneron, approval, pharma

The FDA has expanded the indication for Regeneron’s Eylea (aflibercept) to include all stages of diabetic retinopathy. Regeneron chief scientific …

News
lilly_entrance_web

Lilly’s Cyramza approved in US for hepatocellular carcinoma sub-population

May 13, 2019
Sales and Marketing Eli Lilly, FDA, cyramza, hepatocellular carcinoma, pharma

Eli Lilly’s vascular endothelial growth factor (VEGF) receptor 2 antagonist Cyramza (ramucirumab) has received approval in the US as a …

News
fda2outsideweb

FDA to end controversial “alternative summary reporting” of medical devices in bid to boost transparency

May 10, 2019
Medical Communications, Research and Development, Sales and Marketing FDA, US, adverse events, medical devices, pharma

The FDA has revealed that it plans to terminate its “alternative summary reporting” programme which has allowed the manufacturers of …

News

FDA approves first two drugs for transthyretin amyloid cardiomyopathy

May 7, 2019
Manufacturing and Production, Sales and Marketing FDA, Pfizer, US, Vyndamax, Vyndaqel, pharma

The FDA has approved its first two therapies for the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM), …

News

Sanofi’s Dengvaxia becomes first FDA-approved dengue vaccine, but with caveats…

May 2, 2019
Sales and Marketing FDA, Sanofi, dengue, dengvaxia, pharma

Sanofi has announced that the FDA has granted authorisation to its tetravalent vaccine Dengvaxia for prevention of dengue disease originating …

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40230318504_a38a3dbfde_z

Ambien and other insomnia meds to be labelled with black box warnings after sleepwalking deaths

May 2, 2019
Medical Communications, Research and Development FDA, ambien, black box warning, insomnia, sleeping pills, warning label

The FDA has said that Ambien, and other insomnia medications, must be labelled with a ‘black box warning’ – the …

News
gsk_boronia_australia

GSK’s Benlysta becomes first FDA-approved IV therapy for paediatric lupus

April 30, 2019
Manufacturing and Production, Sales and Marketing Benlysta, FDA, GSK, Lupus, US, pharma

GSK has scored approval in the US with Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE) in paediatric …

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FDA approves Beximco’s generic version of MSD’s allergy drug Periactin

April 25, 2019
Sales and Marketing FDA, MSD, Periactin, allergy, generics, pharma

Bangladesh-based Beximco Pharma is celebrating following the decision from the FDA to approve its generic version of MSD’s antihistamine therapy …

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abbvie_0

AbbVie’s Skyrizi snatches up FDA approval in moderate to severe plaque psoriasis

April 24, 2019
Research and Development, Sales and Marketing AbbVie, FDA, Skyrizi, US, pharma, psoriasis

AbbVie has revealed that its interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab-rzaa) has received marketing authorisation in the US from the FDA …

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merck-keytruda

Keytruda/Inlyta combo scores FDA approval in advanced kidney cancer

April 23, 2019
Manufacturing and Production, Sales and Marketing FDA, MSD, Pfizer, Sutent, inlyta, keytruda, pharma

MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) has secured another approval from the FDA, this time as a first-line treatment in combination …

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Janssen’s Balversa becomes first FDA-approved FGFR kinase inhibitor for advanced bladder cancer

April 15, 2019
Sales and Marketing Balversa, Cancer, FDA, Janssen, bladder cancer, pharma

Janssen’s Balversa (erdafitinib) has become the first FDA-approved fibroblast growth factor receptor (FGFR) kinase inhibitor after the US agency authorised …

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fdaoutsideweb

FDA green lights Amgen and UCB’s Evenity in postmenopausal osteoporosis patients

April 10, 2019
Research and Development, Sales and Marketing Amgen, Evenity, FDA, UCB Pharma, osteoporosis, pharma

The FDA has decided to approve Amgen and UCB Pharma’s Evenity (romosozumab-aqqg) for the treatment of postmenopausal osteoporosis patients at …

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FDA refuses to review Zogenix’s Fintepla in Dravet syndrome, shares tumble 30%

April 9, 2019
Manufacturing and Production, Sales and Marketing Dravet Syndrome, FDA, Fintepla, Zogenix

California-based biopharma firm Zogenix has been left frustrated after it received a correspondence from the FDA noting its refusal to …

News

FDA approves Pfizer’s Ibrance for advanced male breast cancer

April 5, 2019
Medical Communications, Sales and Marketing Cancer, FDA, Pfizer, breast cancer, ibrance, male breast cancer, pharma

The FDA has chosen to expand the indications of Pfizer’s Ibrance (palbociclib), the company announced, approving the CDK4/6 inhibitor in …

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Novartis’ new MS drug to cost $88,000 a year

March 27, 2019
Research and Development, Sales and Marketing FDA, MS, Novartis, Novartis pharmaceuticals, multiple sclerosis

Paul Hudson, the CEO of Swiss firm Novartis Pharmaceuticals has said the company’s newly approved multiple sclerosis (MS) drug will …

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