Blog
RSS FeedPosted by Michael Wonder on 06 May 2021
Viome receives FDA approval for its unique mRNA technology and AI platform to detect cancers
6 May 2021 - FDA breakthrough designation validates Viome's proprietary mRNA analysing technology and state of the art AI platform to ...
Posted by Michael Wonder on 06 May 2021
Injectafer (ferric carboxymaltose injection) receives FDA approval for single dose option for the treatment of adult patients with iron deficiency anaemia
6 May 2021 - For patients weighing 50 kg (110 lb) or more, Injectafer may now be administered as a 1000 ...
Posted by Michael Wonder on 06 May 2021
Merck and Eisai receive priority review from FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) applications for advanced renal cell carcinoma and for advanced endometrial carcinoma
6 May 2021 - Applications based on progression-free survival, overall survival, and objective response rate data from respective pivotal Phase 3 ...
Posted by Michael Wonder on 06 May 2021
Medicines Australia updated position on intellectual property (in light of TRIPS waiver)
6 May 2021 - Medicines Australia continues to express our sympathies to all those affected by the pandemic. The importance ...
Posted by Michael Wonder on 06 May 2021
Designing an independent public health agency
6 May 2021 - The COVID-19 pandemic has revealed the importance of having trustworthy and competent institutions to protect public ...
Posted by Michael Wonder on 06 May 2021
Australia has backed a global push to fast-track generic COVID-19 jabs
6 May 2021 - The Morrison government has joined an international push to fast-track the production of generic COVID-19 jabs, ...
Posted by Michael Wonder on 06 May 2021
European Commission approves Benlysta for adult patients with active lupus nephritis
5 May 2021 - First and only biologic approved for both systemic lupus erythematosus and lupus nephritis ...
Posted by Michael Wonder on 06 May 2021
Health Canada issues Notice of Compliance for Bausch Health's Bryhali
5 May 2021 - Bausch Health Canada today announced that Health Canada has approved the use of Bryhali (halobetasol propionate 0.01% ...
Posted by Michael Wonder on 05 May 2021
BioNTech nearing request for approval of longer lasting version of COVID vaccine
4 May 2021 - BioNTech is working on getting approval for a version of its COVID-19 vaccine which can be ...
Posted by Michael Wonder on 05 May 2021
Pfizer says it will seek clearance in September for its vaccine to be used in children aged 2 to 11
4 May 2021 - Pfizer expects to apply to the FDA in September for emergency authorisation to administer its coronavirus ...
Posted by Michael Wonder on 05 May 2021
Health Canada authorises use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age
5 May 2021 - Today, Health Canada authorised the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 ...
Posted by Michael Wonder on 05 May 2021
FDA grants accelerated approval to pembrolizumab for HER2 positive gastric cancer
5 May 2021 - Today the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, ...
Posted by Michael Wonder on 05 May 2021
FDA accepts Amgen's supplemental new drug application for Otezla (apremilast) for adults with mild to moderate plaque psoriasis
5 May 2021 - Acceptance based on data from Phase 3 ADVANCE trial, demonstrating clinically meaningful improvements through week 32. ...
Posted by Michael Wonder on 05 May 2021
US FDA accepts GC Pharma’s biologics license application for immunoglobulin 'GC5107'
5 May 2021 - A significant milestone towards entering the world's largest plasma product marketplace. ...
Posted by Michael Wonder on 05 May 2021
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib) in IDH1 mutated cholangiocarcinoma
5 May 2021 - Servier Pharmaceuticals today announced that the U.S. FDA has accepted the company's supplemental new drug application for ...