Blog
RSS FeedPosted 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 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
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 18 Aug 2021
WHO calls on Roche to ensure fair access to COVID-19 drug amid shortage
18 August 2021 - The World Health Organization called on Wednesday on Roche to ensure fair distribution of its arthritis ...
Posted by Michael Wonder on 18 Aug 2021
FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump
18 August 2021 - The United States FDA has granted breakthrough device designation to Abiomed’s Impella ECP expandable percutaneous heart ...
Posted by Michael Wonder on 18 Aug 2021
US FDA approves Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction
18 August 2021 - New treatment options are critical, as approximately half of all people with heart failure die within five ...
Posted by Michael Wonder on 18 Aug 2021
Sutro Biopharma announces STRO-002 FDA fast track designation for patients with advanced ovarian cancer
18 August 2021 - Sutro Biopharma today announced that the U.S. FDA has granted fast track designation for STRO-002, a folate ...
Posted by Michael Wonder on 18 Aug 2021
Joint statement from HHS public health and medical experts on COVID-19 booster shots
18 August 2021 - Today, public health and medical experts from the U.S. Department of Health and Human Services released the ...
Posted by Michael Wonder on 18 Aug 2021
Update on Actemra (tocilizumab) supply in the U.S.
16 August 2021 - The unprecedented surge in worldwide demand and supply constraints driven by Delta variant spikes in much ...
Posted by Michael Wonder on 18 Aug 2021
Pharmaceutical companies should pay for raiding nature's medicine cabinet
11 August 2021 - In 2019, the pharmaceutical industry profited from US$1·2 trillion of global spending on medicines. Most of this ...
Posted by Michael Wonder on 17 Aug 2021
Tempus submits PMA application to the FDA for its xT-Onco assay
17 August 2021 - Tempus today announced the submission of a premarket approval application for its proprietary broad-panel DNA sequencing ...
Posted by Michael Wonder on 17 Aug 2021
Agios announces FDA acceptance and priority review of new drug application for mitapivat for treatment of adults with pyruvate kinase deficiency
17 August 2021 - PDUFA date set for 17 February 2022. ...
Posted by Michael Wonder on 17 Aug 2021
FDA grants accelerated approval of Jemperli (dostarlimab-gxly) for dMMR recurrent or advanced solid tumours
17 August 2021 - Second FDA approval of PD-1 antagonist antibody under clinical development for solid tumours in collaboration with GSK. ...