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RSS FeedPosted by Michael Wonder on 24 Jun 2023
Pfizer and BioNTech submit applications to US FDA for Omicron XBB.1.5 adapted monovalent COVID-19 vaccine
23 June 2023 - The submissions reflect guidance from FDA and other major health authorities to provide COVID-19 vaccines better matched ...
Posted by Michael Wonder on 23 Jun 2023
Moderna files for FDA authorisation of its updated COVID-19 vaccine
22 June 2023 - Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent ...
Posted by Michael Wonder on 26 Apr 2023
Atea Pharmaceuticals announces US FDA fast track designation granted to bemnifosbuvir, an investigational oral anti-viral, for the treatment of COVID-19
25 April 2023 - Atea Pharmaceuticals today announced that the United States FDA has granted fast track designation to bemnifosbuvir for ...
Posted by Michael Wonder on 04 Apr 2023
FDA authorises Gohibic (vilobelimab) injection for the treatment of COVID-19
4 April 2023 - The FDA has issued an emergency use authorisation for the use of Gohibic (vilobelimab) injection for ...
Posted by Michael Wonder on 22 Mar 2023
Drug repurposing during the COVID-19 pandemic: lessons for expediting drug development and access
20 March 2023 - The COVID-19 pandemic created a large, sudden unmet public health need for rapid access to safe and ...
Posted by Michael Wonder on 15 Mar 2023
FDA authorises bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age
14 March 2023 - Today, the US FDA amended the emergency use authorisation of the Pfizer-BioNTech COVID-19 vaccine, bivalent to provide ...
Posted by Michael Wonder on 01 Mar 2023
Pfizer and BioNTech submit for US emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 booster in children under 5 years
1 March 2023 - Pfizer and BioNTech today submitted an application to the US FDA for emergency use authorisation of ...
Posted by Michael Wonder on 27 Feb 2023
Pfizer and BioNTech submit supplemental biologics license application for US FDA approval of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine for ages 12 years and older as primary series or booster
24 February 2023 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the US ...
Posted by Michael Wonder on 26 Jan 2023
Update on US FDA emergency use authorisation of Evusheld
26 January 2023 - The US FDA has stated that AstraZeneca’s Evusheld (tixagevimab and cilgavimab) is not currently authorised for ...
Posted by Michael Wonder on 10 Jan 2023
Moderna considers price of $110-$130 for COVID-19 vaccine
9 January 2023 - Commercial price is similar to Pfizer’s plans for after government contracting ends. ...
Posted by Michael Wonder on 21 Dec 2022
FDA approves Genentech’s Actemra for the treatment of COVID-19 in hospitalised adults
21 December 2022 - Actemra is the first FDA approved monoclonal antibody to treat COVID-19. ...
Posted by Michael Wonder on 10 Dec 2022
Pfizer and BioNTech receive US FDA fast track designation for single dose mRNA based vaccine candidate against COVID-19 and influenza
9 December 2022 - Pfizer and BioNTech today announced the companies have received fast track designation from the US FDA ...
Posted by Michael Wonder on 08 Dec 2022
FDA authorises updated (bivalent) COVID-19 vaccines for children down to 6 months of age
8 December 2022 - Today, the US FDA amended the emergency use authorisations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 ...
Posted by Michael Wonder on 07 Dec 2022
US backs delay to decision on COVID patent waiver extension
6 December 2022 - The United States on Tuesday urged delaying a decision on whether to waive patent protection for ...
Posted by Michael Wonder on 06 Dec 2022
Pfizer and BioNTech submit application to US FDA for emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine in children under 5 years
5 December 2022 - Pfizer andBioNTech today announced that the companies have submitted an application to the US FDA for ...