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 05 Jul 2021
It’s time for the FDA to fully approve the mRNA vaccines
1 July 2021 - Here’s a paradox: a new drug for Alzheimer’s disease, aducanumab, gets approved by the FDA through an ...
Posted by Michael Wonder on 05 Jul 2021
Merck provides update on Keytruda (pembrolizumab) indication in third-line gastric cancer in the US
1 July 2021 - Merck today announced that the company plans to voluntarily withdraw the U.S. accelerated approval indication for Keytruda ...
Posted by Michael Wonder on 05 Jul 2021
PBAC Public Summary Document for risdiplam – March 2021 meeting
5 July 2021 - The Public Summary Document for risdiplam from the March 2021 PBAC meeting is now available. ...
Posted by Michael Wonder on 05 Jul 2021
Diurnal receives marketing authorisation for Efmody in Great Britain from the MHRA
2 July 2021 - Efmody provides a new treatment option for c.5,000 patients suffering from congenital adrenal hyperplasia in Great Britain. ...
Posted by Michael Wonder on 05 Jul 2021
Statement for health care professionals: how COVID-19 vaccines are regulated for safety and effectiveness
5 July 2021 - Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization. ...
Posted by Michael Wonder on 05 Jul 2021
Medical devices reforms: enhancements to post-market monitoring
5 July 2021 - This project has been established to enhance the adverse event reporting processes. ...
Posted by Michael Wonder on 04 Jul 2021
Solasia announces submission of new drug application for anti-cancer drug darinaparsin for peripheral T-cell lymphoma in Japan
30 June 2021 - New drug application filed in Japan ahead of anywhere else in the world. ...
Posted by Michael Wonder on 04 Jul 2021
COVID-19 indemnity scheme to protect health professionals and patients
2 July 2021 - The Australian Government is establishing a COVID-19 Vaccine Claim Scheme to provide further assurance and confidence to ...
Posted by Michael Wonder on 04 Jul 2021
Medicare ‘coverage with evidence development’ for aducanumab? How might it work?
30 June 2021 - In the wake of the FDA’s controversial decision to approve aducanumab for Alzheimer’s disease, how will, and ...
Posted by Michael Wonder on 04 Jul 2021
Sonic Healthcare USA to offer assay to aid in the selection of Jemperli (dostarlimab-gxly) therapy in endometrial cancer
2 July 2021 - LMC Pathology Services, a Sonic Healthcare USA Anatomic Pathology Practice, is the first reference laboratory in ...
Posted by Michael Wonder on 04 Jul 2021
Galderma receives FDA approval for Restylane Contour for cheek augmentation and correction of midface contour deficiencies
29 June 2021 - Galderma's first and only product in the U.S. to use proprietary XpresHAn Technology for the cheeks. ...
Posted by Michael Wonder on 04 Jul 2021
ICER to test principle of fair access to fairly priced pharmaceuticals
2 July 2021 - The controversial approval last month by the FDA of Aduhelm (aducanumab) for patients with early-stage Alzheimer’s disease ...
Posted by Michael Wonder on 03 Jul 2021
Iterum Therapeutics provides regulatory update
1 July 2021 - Iterum Therapeutics today announced that the Company received a letter from the U.S.FDA stating that, as ...
Posted by Michael Wonder on 02 Jul 2021
Formycon and Bioeq announce submission of the marketing authorisation application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the EMA
29 June 2021 - Formycon and its license partner Bioeq AG announce that the marketing authorisation application for FYB201, Formycon’s ...
Posted by Michael Wonder on 02 Jul 2021
PBAC Public Summary Documents – March 2021 meeting
2 July 2021 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the March 2021 PBAC ...