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RSS FeedPosted by Michael Wonder on 19 Apr 2021
United Therapeutics announces submission of Tvyaso DPI new drug application to FDA
19 April 2021 - Priority review voucher applied to the submission. ...
Posted by Michael Wonder on 19 Apr 2021
Agenus submits balstilimab biologics license application to the U.S. FDA for patients with recurrent or metastatic cervical cancer
19 April 2021 - Submission has been made for review under the accelerated approval pathway ...
Posted by Michael Wonder on 19 Apr 2021
ALK gains paediatric approval for its ragweed SLIT tablet in the USA
19 April 2021 - The approval is based on data from one of the largest-ever paediatric SLIT-tablet trials, involving over 1,000 ...
Posted by Michael Wonder on 19 Apr 2021
Seagen and Astellas announce U.S. FDA acceptance of two supplemental biologics license applications for Padcev (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer
19 April 2021 - Australia and Canada regulators will review applications as part of FDA’s Project Orbis. ...
Posted by Michael Wonder on 19 Apr 2021
European Commission approves second indication of Sarclisa (isatuximab) for relapsed multiple myeloma
19 April 2021 - Approval based on Phase 3 IKEMA study demonstrating Sarclisa added to standard of care carfilzomib and dexamethasone ...
Posted by Michael Wonder on 18 Apr 2021
Greg Hunt confirms ‘high interest’ in producing mRNA vaccines onshore
18 April 2021 - Australia is interested in producing a cutting-edge form of vaccines in Australia, after the nation’s rollout was ...
Posted by Michael Wonder on 18 Apr 2021
Cancer researcher David Thomas says more should be done attract big pharma
18 April 2021 - A Garvan Institute cancer researcher says the government needs to attract big pharmaceutical companies to Australia ...
Posted by Michael Wonder on 17 Apr 2021
Health Canada authorises Evrysdi (risdiplam) for the treatment of spinal muscular atrophy in adults and children
15 April 2021 - Evrysdi (risdiplam) is the first at home administered treatment for spinal muscular atrophy. ...
Posted by Michael Wonder on 17 Apr 2021
Oncopeptides submits application for conditional marketing authorisation of melflufen in the EU
16 April 2021 - Oncopeptides today announces that the Company has submitted an application to the EMA for conditional marketing authorisation ...
Posted by Michael Wonder on 16 Apr 2021
FDA revokes emergency use authorisation for monoclonal antibody bamlanivimab
16 April 2021 - Alternative monoclonal antibody therapies authorised to treat patients with COVID-19 remain available. ...
Posted by Michael Wonder on 16 Apr 2021
FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and oesophageal adenocarcinoma
16 April 2021 - Today, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced ...
Posted by Michael Wonder on 16 Apr 2021
AstraZeneca ChAdOx1-S COVID-19 vaccine
16 April 2021 - Third Australian case of thrombosis with thrombocytopenia likely linked to vaccine. ...
Posted by Michael Wonder on 16 Apr 2021
Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.
16 April 2021 - Final step in Lilly's planned transition to provide only bamlanivimab and etesevimab together in the U.S. ...
Posted by Michael Wonder on 16 Apr 2021
Mayne Pharma and Mithra announce FDA approval of new oral contraceptive Estelle
15 April 2021 - Mayne Pharma Group and Mithra Pharmaceuticals are very pleased to announce that the US FDA has approved ...
Posted by Michael Wonder on 15 Apr 2021
EU drug regulator to issue view on J&J vaccine next week
15 April 2021 - Europe's drug regulator said on Wednesday it planned to issue a recommendation on Johnson & Johnson's ...