Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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
Novo Nordisk expands product offerings in Canada for the treatment of haemophilia A in both children and adults, with availability of Esperoct and Zonovate
1 April 2022 - Newly available treatments can help Canadians living with haemophilia A better manage their bleeding episodes ...
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
Thousands of people set to benefit from first new treatment for osteoporosis for over a decade
1 April 2022 - Thousands of people in England and Wales with severe osteoporosis who are at high risk of fracture ...
Posted by Michael Wonder on 01 Apr 2022
Price slashed for revolutionary $78,000 a year prostate cancer treatment Lynparza
1 April 2022 - A new subsidy for a revolutionary drug is set to benefit thousands of Aussie men with aggressive ...
Posted by Michael Wonder on 01 Apr 2022
Making medicines more affordable for more Australians
1 April 2022 - Australians will have cheaper access to treatments for high cholesterol, heart failure and high blood pressure from ...
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 01 Apr 2022
Public Summary Documents – December 2021 PBAC meeting
1 April 2022 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the December 2021 PBAC ...
Posted by Michael Wonder on 01 Apr 2022
ACE releases latest trance of drug guidances (April 2022)
1 April 2022 - The Agency for Clinical Effectiveness has released another batch of drug guidances. ...
Posted by Michael Wonder on 01 Apr 2022
Funding Trikafta for Kiwis with cystic fibrosis - setting the record straight
31 March 2022 - On Monday 28 March, Carmen Shanks presented her Parliamentary Petition to MP Shanan Halbert, urging the ...
Posted by Michael Wonder on 31 Mar 2022
Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration and diabetic macular oedema
28 March 2022 - The bispecific antibody inhibits two disease pathways that drive nAMD and DME by blocking angiopoietin-2 (Ang-2) and ...