Blog
RSS FeedPosted by Michael Wonder on 24 Jul 2020
MyoKardia announces receipt of breakthrough therapy designation from FDA for mavacamten for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy
23 July 2020 - MyoKardia today announced that the U.S. FDA has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, ...
Posted by Michael Wonder on 23 Jul 2020
Delays to the commencement of certain medical device regulatory changes
23 July 2020 - The Governor-General in Council has made regulations which delay the commencement of a number of medical ...
Posted by Michael Wonder on 23 Jul 2020
FDA proposes new rule on reporting requirements
23 July 2020 - Today, the U.S. FDA published the proposed rule, Annual Summary Reporting Requirements Under the Right to ...
Posted by Michael Wonder on 23 Jul 2020
Potential risks of treatment with unapproved regenerative medicine products
22 July 2020 - Protecting patients is at the core of what we do at the U.S. Food and Drug ...
Posted by Michael Wonder on 23 Jul 2020
ElsaLys Biotech announces submission of biologics license application to FDA for Leukotac (inolimomab) for the treatment of graft versus host disease in adult patients
23 July 2020 - The biologics license application will be reviewed under the FDA’s Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 23 Jul 2020
MC2 Therapeutics announces U.S. Food and Drug Administration approval of Wynzora (calcipotriene 0.005% and betamethasone dipropionate 0.064% cream) for adults with plaque psoriasis
22 July 2020 - MC2 Therapeutics announced today that the U.S. FDA has approved Wynzora (calcipotriene and betamethasone dipropionate, w/w ...
Posted by Michael Wonder on 23 Jul 2020
Spravato (esketamine) nasal spray is available for Canadian patients
22 July 2020 - A new anti-depressant with a novel mechanism of action to treat major depressive disorder in adults. ...
Posted by Michael Wonder on 22 Jul 2020
Jazz Pharmaceuticals announces U.S. FDA approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy
22 July 2020 - Xywav is the first FDA approved new treatment option indicated for both cataplexy and excessive daytime sleepiness ...
Posted by Michael Wonder on 22 Jul 2020
Pfizer vaccine deal at $20 a dose sets ceiling for rivals
22 July 2020 - U.S. agrees to pay Pfizer, BioNTech $1.95 billion on approval. ...
Posted by Michael Wonder on 22 Jul 2020
Australia left in the dark as manufacturers race to make Oxford COVID-19 vaccine
22 July 2020 - Australia may have to compete with other nations to import supply of the University of Oxford's ...
Posted by Michael Wonder on 22 Jul 2020
First Covid-19 vaccine may be approved in 2020, EU regulator says
21 July 2020 - EMA will start rolling review of data, production after summer. ...
Posted by Michael Wonder on 22 Jul 2020
Coronavirus: pharmaceutical giants split on vaccine profits
22 July 2020 - Pharmaceutical companies are split on how they would price their potential COVID-19 vaccines, with some pledging ...
Posted by Michael Wonder on 21 Jul 2020
Aurinia announces U.S. FDA acceptance of the filing of new drug application and priority review for voclosporin for the treatment of lupus nephritis
21 July 2020 - FDA grants priority review and sets PDUFA date of 22 January 2021 . ...
Posted by Michael Wonder on 21 Jul 2020
Harnessing real world data for regulatory use and applying innovative applications
22 July 2020 - A vast quantity of real world data are available to health care researchers. ...
Posted by Michael Wonder on 21 Jul 2020
Use of risk evaluation and mitigation strategies by the US Food and Drug Administration, 2008-2019
21 July 2020 - The US FDA Amendments Act of 2007 gave the FDA authority to require a Risk Evaluation and ...