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 26 Dec 2021
Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council seeks additional data; aducanumab remains under review
22 December 2021 - Biogen and Eisai today announced that the First Committee on New Drugs of the Pharmaceutical Affairs ...
Posted by Michael Wonder on 26 Dec 2021
Investigational Alzheimer’s disease therapy lecanemab granted FDA fast track designation
23 December 2021 - Eisai and Biogen announced today that lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of ...
Posted by Michael Wonder on 26 Dec 2021
Merck and Ridgeback’s molnupiravir, an investigational oral anti-viral COVID-19 treatment, receives special approval for emergency in Japan
24 December 2021 - Molnupiravir, first oral COVID-19 antiviral medicine to receive authorisation in the world, now authorised in U.S., U.K. ...
Posted by Michael Wonder on 23 Dec 2021
FDA authorises first oral antiviral for treatment of COVID-19
22 December 2021 - Today, the U.S. FDA issued an emergency use authorisation for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, ...
Posted by Michael Wonder on 23 Dec 2021
FDA authorises additional oral antiviral for treatment of COVID-19 in certain adults
23 December 2021 - Today, the U.S. FDA issued an emergency use authorisation for Merck’s molnupiravir for the treatment of mild-to-moderate ...
Posted by Michael Wonder on 23 Dec 2021
Allarity Therapeutics submits new drug application to the U.S. FDA for dovitinib for third-line treatment of renal cell carcinoma
22 December 2021 - New drug application is supported by Allarity’s previously-filed pre-market approval submission to the FDA for the ...
Posted by Michael Wonder on 22 Dec 2021
Helsinn Group announces EMA acceptance for review of the marketing authorisation application for infigratinib for patients with cholangiocarcinoma with fibroblast growth factor receptor 2 fusions or rearrangements
21 December 2021 - Helsinn today announced that the EMA accepted for review the Company’s marketing authorisation application for infigratinib for ...
Posted by Michael Wonder on 22 Dec 2021
Intra-Cellular Therapies announces U.S. FDA approval of Caplyta (lumateperone) for the treatment of bipolar depression in adults
20 December 2021 - Caplyta is the only FDA approved treatment for depressive episodes associated with bipolar I or II ...
Posted by Michael Wonder on 22 Dec 2021
FDA approves Otezla (apremilast) for the treatment of adult patients with plaque psoriasis, regardless of severity level
20 December 2021 - Otezla is the first and only oral therapy approved in adult patients with plaque psoriasis across all ...
Posted by Michael Wonder on 22 Dec 2021
Deciphera announces approval of Qinlock in the United Kingdom for the treatment of fourth-line gastro-intestinal stromal tumour
21 December 2021 - Qinlock significantly reduced the risk of disease progression or death by 85% and showed clinically meaningful ...
Posted by Michael Wonder on 22 Dec 2021
Ultomiris regulatory submission accepted under FDA priority review in the US for adults with generalised myasthenia gravis
21 December 2021 - Submission based on positive Phase 3 trial in which Ultomiris significantly improved functional activities as measured ...
Posted by Michael Wonder on 22 Dec 2021
Extension to image based prescription special arrangement
22 December 2021 - The Department of Health has extended the ‘image based prescription’ interim measure which allows the supply of ...
Posted by Michael Wonder on 22 Dec 2021
PHARMAC publishes experts’ advice and seeks views on patient access criteria for COVID-19 treatments
22 December 2021 - PHARMAC is releasing the October meeting records of their COVID-19 clinical expert advisory group and seeking feedback ...
Posted by Michael Wonder on 22 Dec 2021
FDA approves drug to treat, help prevent types of blood clots in certain pediatric populations
20 December 2021 - FDA has approved Xarelto (rivaroxaban) as tablets and an oral suspension to treat venous thromboembolism, or blood ...
Posted by Michael Wonder on 21 Dec 2021
FDA approves first injectable treatment for HIV pre-exposure prevention
20 December 2021 - Drug given every two months rather than daily pill is important tool in effort to end the ...