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 06 Jul 2021
FDA grants priority review for Levo Therapeutics’ new drug application for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome
6 July 2021 - Levo Therapeutics announced today that the U.S. FDA has granted priority review for its new drug application ...
Posted by Michael Wonder on 06 Jul 2021
ANI Pharmaceuticals announces refiling of Cortrophin sNDA with FDA
6 July 2021 - ANI Pharmaceuticals today announced that the Company has re-filed its supplemental new drug application for Cortrophin Gel ...
Posted by Michael Wonder on 06 Jul 2021
Provention Bio receives complete response letter to biologics license application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals
6 July 2021 - Previously reported pharmacokinetic drug product comparability considerations remain outstanding. ...
Posted by Michael Wonder on 06 Jul 2021
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) in locally advanced cutaneous squamous cell carcinoma
6 July 2021 - Keytruda is now approved for the treatment of patients with recurrent or metastatic or locally advanced ...
Posted by Michael Wonder on 06 Jul 2021
Athenex provides update from FDA Type A meeting regarding oral paclitaxel plus encequidar for the treatment of metastatic breast cancer
6 July 2021 - Athenex today announced that the Company held a Type A meeting with the U.S. FDA during the ...
Posted by Michael Wonder on 06 Jul 2021
Opthea’s OPT-302 granted FDA fast track designation for wet age-related macular degeneration
6 July 2021 - FDA’s Fast Track Designation for OPT-302 offers benefits to expedite the OPT-302 Phase 3 clinical program and ...
Posted by Michael Wonder on 06 Jul 2021
DoH publishes revised agenda for July 2021 PBAC meeting
6 July 2021 - Agenda revised on the eve of next scheduled meeting. ...
Posted by Michael Wonder on 06 Jul 2021
The controversial approval of an Alzheimer’s drug reignites the battle over the underlying cause of the disease
6 July 2021 - A new treatment targets amyloid clumps in the brain, but researchers have long debated whether that will ...
Posted by Michael Wonder on 06 Jul 2021
Health Products Portal – outcomes from the 2021-22 Federal Budget
6 July 2021 - In the 2021-22 Budget, the Government announced that it will provide $36.0 million over four years (and ...
Posted by Michael Wonder on 05 Jul 2021
Remdesivir in COVID-19: indication of considerable added benefit for a part of the patients
1 July 2021 - COVID-19 patients with pneumonia who do not yet require high-flow oxygen therapy benefit from remdesivir: they recover ...
Posted by Michael Wonder on 05 Jul 2021
Time for corporate health insurers to front up on savings
29 June 2021 - The Medical Technology Association of Australia has called on the corporate health insurance industry to commit ...
Posted by Michael Wonder on 05 Jul 2021
Major step in COVID-19 vaccine rollout
5 July 2021 - Australia’s COVID-19 vaccine rollout takes a major step forward, with more than 500 GPs around Australia set ...
Posted by Michael Wonder on 05 Jul 2021
New cancer drugs are expensive and often ineffective
5 July 2021 - Many of the new cancer drugs coming onto the market in Belgium are too expensive, 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 ...