Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2019
FDA approves Bayer's Gadavist (gadobutrol) injection as the first and only contrast agent for use in cardiac magnetic resonance imaging in adult patients with known or suspected coronary artery disease
15 July 2019 - Coronary artery disease is an important public health issue-- a disease that affects 16.5 million Americans. ...
Posted by Michael Wonder on 15 Jul 2019
The FDA disagrees with its own expert panels how often?
15 July 2019 - As the FDA grapples with rising pressure to approve new medicines more quickly, a new analysis ...
Posted by Michael Wonder on 15 Jul 2019
Teva announces FDA approval of AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder
15 July 2019 - The first digital maintenance asthma inhaler therapy with integrated sensors joins Teva’s digital rescue inhaler therapy to ...
Posted by Michael Wonder on 15 Jul 2019
Update on US regulatory decision for Farxiga in type 1 diabetes
15 July 2019 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the supplemental ...
Posted by Michael Wonder on 15 Jul 2019
Report on the current status of the use of real‐world data and real‐world evidence in drug development and regulation
10 July 2019 - Radically expanding use of real‐world data and real‐world evidence holds the potential to substantially impact drug development, ...
Posted by Michael Wonder on 14 Jul 2019
How the FDA uses science to speed medical device innovation
11 July 2019 - The MDDT program streamlines the medical device development and review process. ...
Posted by Michael Wonder on 13 Jul 2019
Eton Pharmaceuticals provides update on EM-100 program
12 July 2019 - Eton Pharmaceuticals today announced that the U.S FDA provided Eton’s partner with a complete response letter relating ...
Posted by Michael Wonder on 13 Jul 2019
Janssen submits application to U.S. FDA seeking approval of new Darzalex (daratumumab) subcutaneous formulation
12 July 2019 - Submission inclusive of data from Phase 3 COLUMBA study presented at ASCO. ...
Posted by Michael Wonder on 11 Jul 2019
Biosimilars continue to exhibit market failure
11 July 2019 - From their inception, biosimilars in the U.S. have faced headwinds. ...
Posted by Michael Wonder on 11 Jul 2019
Ensuring patient safety and drug manufacturing quality through partnership with European Union regulators
11 July 2019 - The Mutual Recognition Agreement with the European Union allows FDA to more effectively deploy our inspectional resources ...
Posted by Michael Wonder on 11 Jul 2019
Neurocrine Biosciences announces FDA acceptance of new drug application for opicapone as an adjunctive treatment for patients with Parkinson's disease
10 July 2019 - New drug application based on data from 38 clinical studies, including two Phase III studies, with more ...
Posted by Michael Wonder on 11 Jul 2019
Reforming the Orphan Drug Act for the 21st century
11 July 2019 - The pharmaceutical market has undergone radical changes, including markedly increased prices for rare-disease drugs. ...
Posted by Michael Wonder on 11 Jul 2019
Horizon Therapeutics submits teprotumumab biologics license application for the treatment of active thyroid eye disease
10 July 2019 - Horizon Therapeutics announced today that it has submitted a biologics license application to the U.S. FDA ...
Posted by Michael Wonder on 10 Jul 2019
FDA announces new efforts to expedite generic drug development and marketing to improve patient access to medicines
10 July 2019 - Today, the U.S. FDA announced a draft guidance, Harmonizing Compendial Standards With Drug Application Approval Using the ...
Posted by Michael Wonder on 10 Jul 2019
A Supreme Court ruling may have made it harder to get some info from the FDA
9 July 2019 - Anyone seeking certain information about a medicine from the FDA may have a harder time getting ...