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RSS FeedPosted by Michael Wonder on 04 Apr 2022
Here comes yet another new medicine for patients with MS
4 April 2022 - The TGA has approved Vumerity (diroximel fumarate). ...
Posted by Michael Wonder on 03 Apr 2022
Cook Medical receives FDA breakthrough device designation for Zenith Thoraco+ endovascular system
31 March 2022 - Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received breakthrough device Designation from the US FDA. ...
Posted by Michael Wonder on 02 Apr 2022
DT-216 granted FDA fast track designation for patients with Friedreich's ataxia
30 March 2022 - DT-216 is a novel GeneTAC gene targeted chimera small molecule designed to specifically target the GAA repeat ...
Posted by Michael Wonder on 02 Apr 2022
Califf admits controversy over FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency
31 March 2022 - Robert Califf, the new head of the FDA, admitted Thursday that the agency’s controversial approval of ...
Posted by Michael Wonder on 02 Apr 2022
Y-mAbs announces submission of omburtamab biologics license application to FDA
1 April 2022 - Y-mAbs Therapeutics today announced that on 31 March 2022, the company completed the resubmission of its biologics ...
Posted by Michael Wonder on 01 Apr 2022
FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma
1 April 2022 - Today, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma) for adult patients with ...
Posted by Michael Wonder on 01 Apr 2022
Merck provides update on FDA review of supplemental biologics license application for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 April 2022 - - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug ...
Posted by Michael Wonder on 01 Apr 2022
Reata Pharmaceuticals completes rolling submission of new drug application for omaveloxolone for the treatment of patients with Friedreich’s ataxia
31 March 2022 - If approved, omaveloxolone would become the first therapy indicated for the treatment of patients with Friedreich’s ...
Posted by Michael Wonder on 31 Mar 2022
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
31 March 2022 - EMA, in collaboration with the European Organisation for Research and Treatment of Cancer, has launched the Cancer ...
Posted by Michael Wonder on 31 Mar 2022
Novavax submits request to expand conditional marketing authorisation of COVID-19 vaccine in the European Union to adolescents (ages 12-17)
31 March 2022 - If granted, Nuvaxovid COVID-19 vaccine (recombinant, adjuvanted) would be the first protein-based option for adolescents aged ...
Posted by Michael Wonder on 31 Mar 2022
Outlook Therapeutics submits biologics license application to the U.S. Food and Drug Administration for ONS-5010 as a treatment for wet AMD
31 March 2022 - ONS-5010 / LYTENAVA (bevacizumab-vikg), if approved, expected to receive 12 years of marketing exclusivity. ...
Posted by Michael Wonder on 31 Mar 2022
New drug application resubmission
31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...
Posted by Michael Wonder on 31 Mar 2022
EMA starts review of Sanofi-GSK COVID vaccine application
30 March 2022 - The European Union's drug regulator has started reviewing Sanofi and its British partner GlaxoSmithKline's application seeking ...
Posted by Michael Wonder on 31 Mar 2022
ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV
30 March 2022 - The FDA approval of the first dispersible single tablet regimen containing dolutegravir increases age-appropriate treatment options ...
Posted by Michael Wonder on 31 Mar 2022
COVID-19 vaccine weekly safety report (31 March 2022)
31 March 2022 - To 27 March 2022, the TGA has received 509 reports which have been assessed as likely to ...