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RSS FeedPosted by Michael Wonder on 23 Nov 2020
FDA expands approval of influenza treatment to post-exposure prevention
23 November 2020 - Today, the U.S. FDA expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of ...
Posted by Michael Wonder on 23 Nov 2020
European Commission approves MenQuadfi, the latest innovation in meningococcal vaccination for individuals 12 months of age and older
23 November 2020 - EC approval based on robust data from seven pivotal Phase 2 and 3 trials involving more than ...
Posted by Michael Wonder on 23 Nov 2020
Politics, science and the remarkable race for a coronavirus vaccine
21 November 2020 - The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical ...
Posted by Michael Wonder on 23 Nov 2020
Alexion receives marketing authorisation from European Commission for new formulation of Ultomiris (ravulizumab) with significantly reduced infusion time
20 November 2020 - The new 100 mg/mL formulation will reduce infusion time by approximately 60%, lessening the burden on patients. ...
Posted by Michael Wonder on 21 Nov 2020
FDA approves first treatment for Hutchinson-Gilford progeria syndrome and some progeroid laminopathies
20 November 2020 - Today, the U.S. FDA approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford ...
Posted by Michael Wonder on 21 Nov 2020
ADC Therapeutics announces FDA accepts biologics license application and grants priority review for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
20 November 2020 - Prescription Drug User Fee Act target action date of 21 May 2021. ...
Posted by Michael Wonder on 21 Nov 2020
Pfizer and BioNTech to submit emergency use authorisation request today to the U.S. FDA for COVID-19 vaccine
20 November 2020 - In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the ...
Posted by Michael Wonder on 20 Nov 2020
First batch of Oxford University’s vaccine for COVID-19 ready by New Year’s Day
21 November 2020 - The Australian manufacturer of the Oxford University-AstraZeneca COVID-19 vaccine has revealed when the first doses will ...
Posted by Michael Wonder on 20 Nov 2020
Update on remdesivir - EMA will evaluate new data from Solidarity trial
20 November 2020 - EMA is aware that the World Health Organization has updated its guidelines advising against the use ...
Posted by Michael Wonder on 20 Nov 2020
HMA/EMA statement on approval of vaccines
20 November 2020 - Development and deployment of safe and effective vaccines is seen as an essential element in the management ...
Posted by Michael Wonder on 20 Nov 2020
Lilly's neutralising antibody bamlanivimab (LY-CoV555) receives interim authorisation from Health Canada as a treatment for COVID-19
20 November 2020 - Bamlanivimab emerged from collaboration between Lilly and Vancouver-based AbCellera. ...
Posted by Michael Wonder on 20 Nov 2020
Imfinzi approved in the US for less-frequent, fixed-dose use
20 November 2020 - Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 20 Nov 2020
FDA grants breakthrough designation to 4D Path for novel cancer diagnostic solution
18 November 2020 - 4D Path today announced that the U.S. FDA has granted the company breakthrough device designation for ...
Posted by Michael Wonder on 20 Nov 2020
PTC Therapeutics announces key regulatory designations for PTC596 to advance treatment of two rare oncology indications
18 November 2020 - PTC Therapeutics today announced that the United States FDA has granted PTC596 both orphan drug designation and ...
Posted by Michael Wonder on 20 Nov 2020
Lumicell granted fast track designation approval by the FDA for breast cancer treatment
18 November 2020 - Fast track designation augments previously granted breakthrough device designation. ...