Blog
RSS FeedPosted 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 12 May 2017
Oncolytics Biotech announces FDA fast track designation for Reolysin in metastatic breast cancer
8 May 2017 - Oncolytics Biotech announced today that the United States FDA has granted fast track designation for Reolysin, the ...
Posted by Michael Wonder on 12 May 2017
Vericel receives FDA regenerative medicine advanced therapy designation for ixmyelocel-T for the treatment of advanced heart failure due to ischaemic dilated cardiomyopathy
10 May 2017 - Ixmyelocel-T is the first therapy to receive the RMAT designation for the treatment of a serious ...
Posted by Michael Wonder on 12 May 2017
Proteon Therapeutics receives FDA breakthrough therapy designation for vonapanitase
10 May 2017 - Proteon Therapeutics today announced that its investigational treatment, vonapanitase, has received breakthrough therapy designation from the ...
Posted by Michael Wonder on 12 May 2017
SYN-004 (ribaxamase) receives breakthrough therapy designation from U.S. FDA for prevention of clostridium difficile infection
11 May 2017 - FDA action marks first breakthrough therapy designation for clinical program designed to prevent primary clostridium difficile infection. ...
Posted by Michael Wonder on 12 May 2017
Rhythm receives expanded FDA breakthrough therapy designation for setmelanotide for rare genetic disorders of obesity
11 May 2017 - Expands upon previous designation for POMC deficiency obesity. ...
Posted by Michael Wonder on 12 May 2017
FDA grants fast track designation for Celyad’s ischemic heart failure therapy, C-Cure
11 May 2017 - Designation granted on the strength of the evidence in the subset of patients that were responders ...
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
Billions saved because FDA didn't rush approval of Alzheimer's drug
10 May 2017 - The U.S. FDA's decision not to rush approval for Eli Lilly's experimental Alzheimer's treatment solanezumab - ...
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 10 May 2017
Senate confirms Trump's pick for FDA
9 May 2017 - The Senate on Tuesday confirmed Scott Gottlieb, President Trump's nominee to lead the FDA. ...