Blog
RSS FeedPosted by Michael Wonder on 23 Mar 2021
FDA approves pembrolizumab for oesophageal or GEJ carcinoma
22 March 2021 - Today the FDA approved pembrolizumab (Keytruda, Merck Sharp & Dohme) in combination with platinum and fluoropyrimidine-based chemotherapy ...
Posted by Michael Wonder on 22 Mar 2021
Oakrum Pharma and Aucta Pharma announce U.S. FDA approval of generic version of Jadenu Sprinkle (deferasirox granules)
22 March 2021 - Oakrum Pharma in collaboration with Aucta Pharmaceuticals announced today the U.S. approval of a generic version of ...
Posted by Michael Wonder on 22 Mar 2021
ATAGI statement and clinical guidance on AstraZeneca COVID-19 vaccine following EMA safety review
19 March 2021 - This statement from the Australian Technical Advisory Group on Immunisation updates advice previous provided on 16 March. ...
Posted by Michael Wonder on 22 Mar 2021
EU has 'absolutely no need' of Russia's Sputnik V vaccine, commissioner says
21 March 2021 - The European Union does not need Russia's Sputnik V vaccine for Covid-19 and can achieve immunity ...
Posted by Michael Wonder on 21 Mar 2021
TGA approves CSL - Seqirus to manufacture AstraZeneca COVID-19 vaccine in Australia
21 March 2021 - Earlier today, the Therapeutic Goods Administration approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia. ...
Posted by Michael Wonder on 21 Mar 2021
AstraZeneca vaccine allowed by government regulators to be produced in Australia
21 March 2021 - Astra Zeneca vaccines will be produced in Australia from now on after the regulators approved doses being ...
Posted by Michael Wonder on 20 Mar 2021
FDA authorises first machine learning-based screening device to identify certain biomarkers that may indicate COVID-19 infection
19 March 2021 - Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a ...
Posted by Michael Wonder on 19 Mar 2021
Senate narrowly confirms Becerra as health secretary
18 March 2021 - Republican Sen. Susan Collins joined all of the Democrats present in the 50-49 vote. ...
Posted by Michael Wonder on 19 Mar 2021
Too fast or too slow: is the FDA moving at the right speed?
19 March 2021 - Regardless of President Joe Biden’s choice for the next commissioner of the FDA, the Senate Health, Education, ...
Posted by Michael Wonder on 19 Mar 2021
Janssen announces U.S. FDA approval of Ponvory (ponesimod), an oral treatment for adults with relapsing multiple sclerosis proven superior to Aubagio (teriflunomide) in reducing annual relapses and brain lesions
19 March 2021 - Ponvory is the first and only FDA approved oral disease modifying therapy studied against an established oral ...
Posted by Michael Wonder on 19 Mar 2021
U.S. FDA accepts Bristol Myers Squibb’s application for mavacamten in symptomatic obstructive hypertrophic cardiomyopathy
19 March 2021 - Application based on results from the Phase 3 EXPLORER-HCM trial. ...
Posted by Michael Wonder on 19 Mar 2021
Seqirus announces Health Canada approval of expanded age indication of its cell-based quadrivalent influenza vaccine for people two years of age and older
18 March 2021 - Seqirus announced that Health Canada has approved Flucelvax Quadrivalent (influenza vaccine), its cell-based quadrivalent influenza vaccine, for ...
Posted by Michael Wonder on 19 Mar 2021
Data on AstraZeneca vaccine insufficient for Swiss approval
18 March 2021 - The medicines regulator Swissmedic says it has not yet received enough robust data from clinical trials ...
Posted by Michael Wonder on 18 Mar 2021
Kiniksa announces FDA approval of Arcalyst (rilonacept) for recurrent pericarditis
18 March 2021 - Kiniksa launches Kiniksa One Connect patient support program. ...
Posted by Michael Wonder on 18 Mar 2021
Novartis' Kisqali (ribociclib) product monograph in Canada now includes MONALEESA-3 data demonstrating statistically significant improvement in overall survival in postmenopausal women with HR+/HER2- advanced breast cancer
18 March 2021 - Kisqali is currently the only CDK4/6 inhibitor that has demonstrated statistically significant improvement in overall survival (key ...