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 22 Jan 2021
Yescarta approved in Japan for treatment of patients with relapsed/refractory large B-cell lymphomas
22 January 2021 - Approval based on phase 2 study conducted in Japan and previous pivotal trial data. ...
Posted by Michael Wonder on 22 Jan 2021
Incyte announces acceptance and priority review of BLA for retifanlimab as a potential treatment for patients with squamous cell carcinoma of the anal canal
21 January 2021 - Incyte today announced that the U.S. FDA has accepted for priority review its biologics license application for ...
Posted by Michael Wonder on 22 Jan 2021
NICE recommends Jyseleca (filgotinib) on NHS in landmark decision for rheumatoid arthritis
21 January 2021 - NICE guidance, for the first time in the UK, supports access to an advanced therapy for people ...
Posted by Michael Wonder on 21 Jan 2021
FDA approves first extended release, injectable drug regimen for adults living with HIV
21 January 2021 - The U.S. FDA today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the ...
Posted by Michael Wonder on 21 Jan 2021
The marathon of COVID-19 vaccination
20 January 2021 - It has been described as a race between infections and injections. If so, infections are still winning. ...
Posted by Michael Wonder on 21 Jan 2021
Italy ponders suing Pfizer for delays in coronavirus vaccine
21 January 2021 - Italy's coronavirus commissioner is pressing ahead with plans to take legal action against Pfizer after the ...
Posted by Michael Wonder on 21 Jan 2021
Biden appoints veteran Woodcock as interim FDA commissioner
21 January 2021 - Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden ...
Posted by Michael Wonder on 21 Jan 2021
Mobilising Australia’s COVID-19 vaccine workforce
21 January 2021 - The Australian Government is securing an additional vaccine workforce and working to deliver essential training to everyone ...
Posted by Michael Wonder on 21 Jan 2021
Industry pooling helps maintain affordability of high cost drugs despite significant inflationary pressures
21 January 2021 - In 2019, the Canadian Drug Insurance Pooling Corporation's (CDIPC) high-cost drug sharing framework provided coverage to ...
Posted by Michael Wonder on 21 Jan 2021
FDA grants priority review to Genentech’s Esbriet (pirfenidone) for unclassifiable interstitial lung disease
21 January 2021 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted ...
Posted by Michael Wonder on 21 Jan 2021
NICE publishes final guidance backing Jyseleca for rheumatoid arthritis
21 January 2021 - NICE has published its final appraisal determination recommending the use of Gilead Sciences and Galapagos’ Jyseleca ...
Posted by Michael Wonder on 21 Jan 2021
Human medicines: highlights of 2020
21 January 2021 - EMA has published an PDF iconoverview of its key recommendations in 2020 on the authorisation and ...
Posted by Michael Wonder on 21 Jan 2021
Who goes first? Government leaders and prioritisation of SARS-CoV-2 vaccine
20 January 2021 - The vice president, Senate majority leader, House speaker, surgeon general, and members of Congress were among the ...
Posted by Michael Wonder on 21 Jan 2021
Sanofi’s RSV treatment nirsevimab awarded PIM status
20 January 2021 - Sanofi’s nirsevimab has been awarded a Promising Innovative Medicine designation by the Medicines and Healthcare Products ...
Posted by Michael Wonder on 21 Jan 2021
Impel NeuroPharma announces U.S. FDA acceptance of new drug application for INP104 for the acute treatment of migraine
20 January 2021 - FDA conditionally accepts trade name, Trudhesa, pending approval of the new drug application, and sets PDUFA goal ...