Blog
RSS FeedPosted 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 18 May 2017
Health Canada approves Opdivo (nivolumab) for the treatment of squamous cell carcinoma of the head and neck
17 May 2017 - Latest approval of Opdivo marks the fourth indication for the immuno-oncology treatment offering hope for improved ...
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 17 May 2017
Viberzi now approved in Canada for patients with irritable bowel syndrome with diarrhoea
May 16 2017 - Allergan is pleased to announce the Health Canada approval of Viberzi (eluxadoline) for the treatment of ...
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
European Commission grants approval for Merck’s new Pergoveris pen for fertility treatment
10 May 2017 - With this approval, Pergoveris becomes the first product with a combination of FSH and LH hormones ...
Posted by Michael Wonder on 11 May 2017
European Commission approves the only immunotherapy for high-risk neuroblastoma, bringing hope to thousands of children affected by a rare and devastating form of cancer
9 May 2017 - EUSA Pharma today announced that the European Commission has approved the antibody ch14.18/CHO, dinutuximab beta, for the ...
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 ...
Posted by Michael Wonder on 11 May 2017
Efficient trial design — FDA approval of valbenazine for tardive dyskinesia
10 May 2017 - A well-executed development program that addresses both regulatory and clinical requirements is critical for making novel therapeutics ...
Posted by Michael Wonder on 11 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic non-squamous non-small-cell lung cancer, irrespective of PD-L1 expression
10 May 2017 - First approval for an anti-PD-1 therapy as a combination in metastatic non-squamous NSCLC. ...
Posted by Michael Wonder on 10 May 2017
FDA grants Bavencio (avelumab) approval for a common type of advanced bladder cancer
9 May 2017 - Second approval for Bavencio in less than two months. ...
Posted by Michael Wonder on 09 May 2017
Cipher Pharmaceuticals receives Health Canada approval of Ozanex (ozenoxacin 1% cream)
8 May 2017 - Cipher Pharmaceuticals today announced the Health Canada approval of Ozanex (ozenoxacin 1% cream) a novel topical ...
Posted by Michael Wonder on 09 May 2017
TherapeuticsMD receives complete response letter from FDA for TX-004HR new drug application
8 May 2017 - No approvability issues identified by FDA related to efficacy or CMC. ...