Blog
RSS FeedPosted by Michael Wonder on 16 Jul 2019
FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab
16 July 2019 - FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises in patients ...
Posted 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 13 Jul 2019
Esperoct is now approved in Canada for the treatment of haemophilia A in both children and adults
12 July 2019 - New treatment can help Canadians living with haemophilia A better manage their bleeding episodes ...
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
Health Canada has authorised Vyvanse (lisdexamphetamine dimesylate), the first and only, chewable tablet for the treatment of attention deficit/hyperactivity disorder
10 July 2019 - Vyvanse offers an additional option for patients who prefer the convenience of a chewable tablet, or who ...
Posted by Michael Wonder on 11 Jul 2019
Health Canada approves Pomalyst-based triplet combination for patients with multiple myeloma
10 July 2019 - Pomalyst in combination with bortezomib and dexamethasone, provides a new medication option for patients living with multiple ...