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 01 Dec 2021
EMA validates Atara Biotherapeutics' marketing authorisation application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
30 November 2021 - First ever off the shelf allogeneic T-cell therapy to be reviewed by any regulatory agency in the ...
Posted by Michael Wonder on 01 Dec 2021
TGA approves Nexviazyme
1 December 2021 - Avalglucosidase alfa (Nexviazyme) is a recombinant form of human acid α-glucosidase. ...
Posted by Michael Wonder on 01 Dec 2021
NICE terminates appraisal of new treatment for adolescents with obesity
1 December 2021 - NICE is unable to make a recommendation on liraglutide (Saxenda) for managing obesity in adolescents aged 12 ...
Posted by Michael Wonder on 30 Nov 2021
Hepion Pharmaceuticals receives FDA fast track designation for CRV431 for the treatment of NASH
30 November 2021 - Hepion Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for the Company’s lead ...
Posted by Michael Wonder on 30 Nov 2021
AMF Medical receives FDA breakthrough device designation for its Sigi insulin management system
30 November 2021 - Sigi is the only insulin patch pump for closed loop integration designed for use with standard, pre-filled ...
Posted by Michael Wonder on 30 Nov 2021
Merck’s Keytruda (pembrolizumab) approved in Japan in combination with chemotherapy for first-line treatment of patients with radically unresectable, advanced or recurrent oesophageal carcinoma
30 November 2021 - Keytruda is now approved for 16 indications in Japan. ...
Posted by Michael Wonder on 30 Nov 2021
Schedule of Pharmaceutical Benefits - 1 December 2021
1 December 2021 - The December 2021 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for patients with certain types of endometrial carcinoma
29 November 2021 - Approval based on KEYNOTE-775/Study 309 results demonstrating statistically significant improvements in overall survival and progression-free survival ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) as first-line treatment for adult patients with advanced renal cell carcinoma
29 November 2021 - Approval Based on Results From CLEAR/KEYNOTE-581 Trial Demonstrating KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of ...
Posted by Michael Wonder on 30 Nov 2021
New Zealand Pharmaceutical Schedule - 1 December 2021
1 December 2021 - The December 2021 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 30 Nov 2021
AbbVie submits application for risankizumab (Skyrizi) in moderate to severe Crohn's disease to European Medicines Agency
30 November 2021 - Submission supported by three pivotal Phase 3 trials in which risankizumab demonstrated significant improvements in clinical remission ...
Posted by Michael Wonder on 30 Nov 2021
The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain
30 November 2021 - Camurus today announces that the EMA has accepted the company’s submission of a Type II variation application ...
Posted by Michael Wonder on 30 Nov 2021
Over 600 people set to benefit from innovative lung cancer treatment within the Cancer Drugs Fund
30 November 2021 - More than 600 people could benefit from an innovative drug for a form of lung cancer ...
Posted by Michael Wonder on 30 Nov 2021
Junshi Biosciences announces approval of supplemental new drug application by NMPA for toripalimab in combination with cisplatin and gemcitabine as first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma
30 November 2021 - Fourth approved indication for toripalimab. ...
Posted by Michael Wonder on 30 Nov 2021
TRACON Pharmaceuticals reports regulatory approval of envafolimab in China
29 November 2021 - First approval of a subcutaneously administered checkpoint inhibitor. ...