FDA
FDA greenlights Roche and AbbVie’s Venclexta for chronic lymphocytic leukaemia
May 16, 2019Sales and Marketing AbbVie, Cancer, FDA, Roche, Venclexta, leukaemia, pharma
Venclexta (venetoclax), the oral B-cell lymphoma-2 (BCL-2) inhibitor co-developed by AbbVie and Roche, has been approved by the FDA in …
Two Daiichi Sankyo drugs dealt a thumbs up and thumbs down by FDA advisory panel
May 15, 2019Research and Development, Sales and Marketing Daiichi Sankyo, FDA, pexidartinib, pharma, quizartinib
Daiichi Sankyo was left with a bittersweet taste in its mouth after it saw one of its drugs recommended for …
Pfizer & Merck’s Inlyta combo becomes first FDA-approved anti-PD-L1 therapy for kidney cancer
May 15, 2019Research and Development, Sales and Marketing FDA, Merck KGaA, Pfizer, inylta, pharma, renal cell carcinoma
The FDA has approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the treatment of advanced renal cell carcinoma (RCC). …
FDA expands indication for Eylea to cover all stages of diabetic retinopathy
May 14, 2019Manufacturing 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 …
Lilly’s Cyramza approved in US for hepatocellular carcinoma sub-population
May 13, 2019Sales 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 …
FDA to end controversial “alternative summary reporting” of medical devices in bid to boost transparency
May 10, 2019Medical 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 …
FDA approves first two drugs for transthyretin amyloid cardiomyopathy
May 7, 2019Manufacturing 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), …
Sanofi’s Dengvaxia becomes first FDA-approved dengue vaccine, but with caveats…
May 2, 2019Sales 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 …
Ambien and other insomnia meds to be labelled with black box warnings after sleepwalking deaths
May 2, 2019Medical 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 …
GSK’s Benlysta becomes first FDA-approved IV therapy for paediatric lupus
April 30, 2019Manufacturing 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 …
FDA approves Beximco’s generic version of MSD’s allergy drug Periactin
April 25, 2019Sales 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 …
AbbVie’s Skyrizi snatches up FDA approval in moderate to severe plaque psoriasis
April 24, 2019Research 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 …
Keytruda/Inlyta combo scores FDA approval in advanced kidney cancer
April 23, 2019Manufacturing 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 …
Janssen’s Balversa becomes first FDA-approved FGFR kinase inhibitor for advanced bladder cancer
April 15, 2019Sales 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 …
FDA green lights Amgen and UCB’s Evenity in postmenopausal osteoporosis patients
April 10, 2019Research 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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Five Facts about cardiovascular disease
