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RSS FeedPosted 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
TGA approves name change of COVID-19 Vaccine AstraZeneca to Vaxzevria
19 August 2021 - The Therapeutic Goods Administration has approved AstraZeneca's submission to change the name of its COVID-19 Vaccine ...
Posted by Michael Wonder on 19 Aug 2021
BeiGene announces acceptance by Swissmedic of marketing authorisation application for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
18 August 2021 - BeiGene announced that Swissmedic has accepted the marketing authorisation application for Brukinsa, a treatment option for adult ...
Posted by Michael Wonder on 19 Aug 2021
COVID-19 vaccine weekly safety report (19 August 2021)
19 August 2021 - To 15 August 2021, approximately 15.3 million vaccine doses have been given in Australia – 9.9 million ...
Posted by Michael Wonder on 19 Aug 2021
Miravo Healthcare announces receipt of Health Canada Notice of Compliance for the paediatric use of Blexten
12 August 2021 - Blexten Label Expanded to Include Ages as Young as 4 Years Old. ...
Posted by Michael Wonder on 19 Aug 2021
TGA reduces timeframe for publishing adverse event reports
19 August 2021 - With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our ...
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 ...