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RSS FeedPosted by Michael Wonder on 30 May 2017
FDA approves first generic Strattera for the treatment of ADHD
30 May 2017 - The U.S. FDA today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder ...
Posted by Michael Wonder on 28 May 2017
Sunovion receives complete response letter from FDA for SUN-101/eFlow (glycopyrrolate) new drug application for chronic obstructive pulmonary disease
26 May 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA issued a complete response letter for the new ...
Posted by Michael Wonder on 27 May 2017
Drug approvals bounce back as R&D labs churn out new winners
25 May 2017 - The number of new drugs approved for sale in United States and Europe has bounced back ...
Posted by Michael Wonder on 26 May 2017
Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer
26 May 2017 - In ALK-positive metastatic NSCLC patients, Zykadia median progression-free survival was 16.6 months, compared to 8.1 months with ...
Posted by Michael Wonder on 25 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient cancer
23 May 2017 - Keytruda now approved for patients with MSI-H or mismatch repair deficient solid tumours that have progressed following ...
Posted by Michael Wonder on 23 May 2017
FDA approves first cancer treatment for any solid tumour with a specific genetic feature
23 May 2017 - The U.S. FDA today granted accelerated approval to a treatment for patients whose cancers have a ...
Posted by Michael Wonder on 23 May 2017
Sanofi and Regeneron announce FDA approval of Kevzara (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients
22 May 2017 - Kevzara is now available to U.S. patients. ...
Posted by Michael Wonder on 22 May 2017
FDA approves first drug to specifically treat giant cell arteritis
22 May 2017 - The U.S. FDA today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with ...
Posted by Michael Wonder on 20 May 2017
How did Vertex win an FDA approval without running a clinical trial?
19 May 2017 - Vertex Pharmaceuticals scored a minor coup this week when the Food and Drug Administration signed off ...
Posted by Michael Wonder on 18 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
18 May 2017 - Keytruda is the only anti-PD-1 therapy to demonstrate superior overall survival versus chemotherapy in patients with advanced ...
Posted by Michael Wonder on 17 May 2017
FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis
17 May 2017 - The U.S. FDA today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. ...
Posted by Michael Wonder on 13 May 2017
FDA authorises use of new device to treat oesophageal birth defect in babies
12 May 2017 - The U.S. FDA today authorised use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device ...
Posted by Michael Wonder on 11 May 2017
GSK escapes Advair hit for now as second generic bid fails
11 May 2017 - GlaxoSmithKline is likely to escape generic competition to its blockbuster lung drug Advair in the United ...
Posted by Michael Wonder on 11 May 2017
Mylan disagrees with FDA over generic Advair delay
10 May 2017 - Generic drug maker Mylan on Wednesday said it disagrees with the reasoning behind the U.S. FDA's ...
Posted by Michael Wonder on 11 May 2017
The FDA has approved a crazy number of new and groundbreaking drugs this year
9 May 2016 - The FDA has been on a streak of late. Over the weekend, the agency approved the ...