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 20 Aug 2021
NICE draft guidance extends recommendation for sapropterin to pregnant women and people aged up to 22 years with rare inherited metabolic condition phenylketonuria
20 August 2021 - NICE has today issued final draft guidance which now recommends sapropterin (Kuvan; BioMarin) as an option for ...
Posted by Michael Wonder on 20 Aug 2021
Bristol Myers Squibb receives European Commission approval for Abecma (idecabtagene vicleucel), the first anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma
19 August 2021 - Abecma represents the only cell therapy approved for multiple myeloma. ...
Posted by Michael Wonder on 20 Aug 2021
Acting FDA Chief Janet Woodcock ruled out as Biden nominee
19 August 2021 - Woodcock faced backlash over controversial Alzheimer’s drug. ...
Posted by Michael Wonder on 20 Aug 2021
Recommendations made by the PBAC – July 2021
20 August 2021 - Recommendations made by the PBAC in July 2021 relating to the listing of medicines on the PBS ...
Posted by Michael Wonder on 20 Aug 2021
TGA provisionally approves GlaxoSmithKline's COVID-19 treatment sotrovimab (Xevudy)
20 August 2021 - Today, the Therapeutic Goods Administration granted provisional approval to GSK for its COVID-19 treatment - sotrovimab ...
Posted by Michael Wonder on 20 Aug 2021
Astellas receives European Commission approval for first in class Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease
20 August 2021 - Roxadustat is the first orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor available for adult patients with anaemia ...
Posted by Michael Wonder on 19 Aug 2021
CADTH welcomes transfer of drug safety and effectiveness network
13 August 2021 - CADTH welcomes today’s announcement by the Canadian Institutes of Health Research and Health Canada that they ...
Posted by Michael Wonder on 19 Aug 2021
NICE’s health technology assessment methods and processes to be evaluated
19 August 2021 - NICE has launched a public consultation on proposed changes to the way it develops recommendations across ...
Posted by Michael Wonder on 19 Aug 2021
Booster shots ‘make a mockery of vaccine equity,’ the WHO’s Africa director says
19 August 2021 - The Africa director at the World Health Organization, Dr. Matshidiso Moeti, criticized the decisions by some ...
Posted by Michael Wonder on 19 Aug 2021
Contradicting WHO, US advises adults to receive COVID-19 boosters
19 August 2021 - The Biden administration is advising all American adults to receive a COVID-19 booster shot after accumulating ...
Posted by Michael Wonder on 19 Aug 2021
EMA validates Gilead’s marketing authorisation application for lenacapavir, an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
19 August 2021 - EMA MAA validation follows submission of NDA for Lenacapavir to the U.S. FDA. ...
Posted by Michael Wonder on 19 Aug 2021
EndoPredict for breast cancer - the company chose not to participate with data
19 August 2021 - In November 2020, Myriad Genetics chose to refrain from participating in a health economic assessment of EndoPredict. ...
Posted by Michael Wonder on 19 Aug 2021
Senhwa's silmitasertib receives US FDA fast track designation for the treatment of recurrent sonic hedgehog driven medulloblastoma
19 August 2021 - Senhwa Biosciences today announced that the US FDA has granted fast track designation for silmitasertib, a highly ...
Posted by Michael Wonder on 19 Aug 2021
Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy
19 August 2021 - Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps determine which solid tumour patients may ...
Posted by Michael Wonder on 19 Aug 2021
NICE recommends first treatment for rare blood disorder
19 August 2021 - People with a rare blood disorder have access to a new treatment following draft guidance from NICE. ...