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RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 Jul 2020
Grünenthal and Averitas Pharma announce U.S. FDA approval of Qutenza for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet
21 July 2020 - Qutenza is the first and only topical, non-systemic, non-opioid pain treatment of its kind to deliver prescription ...
Posted by Michael Wonder on 21 Jul 2020
Pharma execs say FDA will not lower standards for coronavirus vaccine
21 July 2020 - Drug company executives sought to reassure House Democrats that the federal government is not lowering its ...
Posted by Michael Wonder on 21 Jul 2020
EMA sets up infrastructure for real-world monitoring of COVID-19 treatments and vaccines
21 July 2020 - EMA has now set up an infrastructure to support the monitoring of the efficacy and safety ...
Posted by Michael Wonder on 21 Jul 2020
Molecular Partners provides regulatory update of European and Japanese filings of abicipar pegol
20 July 2020 - Molecular Partners today announced that Allergan, an AbbVie company, has informed Molecular Partners of their intent ...