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 02 Jun 2022
Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree
2 June 2022 - Myovant Sciences and Pfizer announced today that the U.S. FDA accepted for review a supplemental new drug ...
Posted by Michael Wonder on 02 Jun 2022
Accutar Biotechnology announces fast track designation granted by FDA to AC0176 for the treatment of metastatic castration resistant prostate cancer
1 June 2022 - Accutar Biotechnology today announced that the U.S. FDA has granted fast track designation to AC0176 for ...
Posted by Michael Wonder on 02 Jun 2022
Fast track designation granted to MTX110 development for the treatment of recurrent glioblastoma
1 June 2022 - Midatech Pharma is pleased to announce that upon submitting an application to the U.S. FDA, its development ...
Posted by Michael Wonder on 02 Jun 2022
Health Canada OKs Pfizer COVID-19 booster shot for teens ages 16 and 17
1 June 2022 - Canada on Wednesday authorised a single booster shot of Pfizer and partner BioNTech’s COVID-19 vaccine for ...
Posted by Michael Wonder on 02 Jun 2022
Eagle Pharmaceuticals announces submission of new drug application to US FDA for landiolol, a beta-1 adrenergic blocker
1 June 2022 - Submission seeks approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, ...
Posted by Michael Wonder on 01 Jun 2022
Health Canada authorises Vabysmo (faricimab injection) for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular oedema
1 June 2022 - Vabysmo (faricimab injection) is the first bispecific antibody that acts by neutralising both VEGF-A and Ang-2 ...
Posted by Michael Wonder on 01 Jun 2022
VBI Vaccines announces UK MHRA marketing authorisation for PreHevbri, a 3 antigen adult hepatitis B vaccine
1 June 2022 - Approval follows the European Commission’s marketing authorisation, granted in April 2022. ...
Posted by Michael Wonder on 01 Jun 2022
Callous PHARMAC has left too many people in the waiting room of death
2 June 2022 - Early on Wednesday, in Washington DC, our Prime Minister met with the US President, who lauded ...
Posted by Michael Wonder on 01 Jun 2022
Summary of US FDA chimeric antigen receptor T-cell biologics license application approvals from a statistical perspective
25 May 2022 - The approval of tisagenlecleucel and axicabtagene ciloleucel in 2017 marked a milestone in the development of oncology ...
Posted by Michael Wonder on 01 Jun 2022
Cancer, rare disorder advocates call for more radical change after damning PHARMAC review
2 June 2022 - Radical action is needed urgently to tackle the delays patients face in getting the latest drugs for ...
Posted by Michael Wonder on 01 Jun 2022
NICE recommends UCB’s Fintepla for Dravet syndrome
1 June 2022 - UCB has announced that it has received a final appraisal determination from NICE recommending Fintepla (fenfluramine). ...
Posted by Michael Wonder on 01 Jun 2022
Health Minister urges PHARMAC to focus on equity and collaboration
1 June 2022 - PHARMAC will need to engage more with other parts of the health system and the public - ...
Posted by Michael Wonder on 01 Jun 2022
ICER to assess treatment for vasomotor symptoms associated with menopause
1 June 2022 - Report will be subject of Midwest CEPAC meeting in December 2022; draft scoping document open to ...
Posted by Michael Wonder on 01 Jun 2022
FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns
1 June 2022 - Possible increased risk of death outweighs the benefits. ...
Posted by Michael Wonder on 01 Jun 2022
Apellis announces submission of new drug application to the FDA for pegcetacoplan for geographic atrophy
1 June 2022 - Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the United States ...