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RSS FeedPosted 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 ...
Posted by Michael Wonder on 23 Nov 2022
Takeda’s biologics license application for Dengue vaccine candidate (TAK-003) granted priority review by US FDA
23 November 2022 - TAK-003 is being evaluated for the prevention of Dengue disease caused by any Dengue virus serotype ...
Posted by Michael Wonder on 08 Nov 2022
Immunomic Therapeutics receives FDA fast track designation for ITI-3000, a pDNA vaccine, in development for the treatment of Merkel cell carcinoma
8 November 2022 - Immunomic Therapeutics today announced that the US FDA has granted fast track designation to the ITI-3000 program ...
Posted by Michael Wonder on 06 Nov 2022
HLB's US subsidiary scores FDA fast track designation for Merkel cell cancer vaccine
4 November 2022 - HLB said on Friday that the anti-cancer vaccine candidate ITI-3000 aiming to treat Merkel cell cancer ...
Posted by Michael Wonder on 04 Nov 2022
Codagenix receives FDA fast track designation for live attenuated, intranasal RSV vaccine candidate CodaVax-RSV
2 November 2022 - Codagenix today announced that the US FDA has granted fast track designation to CodaVax-RSV, an intranasal, live ...
Posted by Michael Wonder on 02 Nov 2022
GSK’s respiratory syncytial virus older adult vaccine candidate granted priority review by US FDA
2 November 2022 - US FDA has set a Prescription Drug User Fee Act action date of 3 May 2023. ...
Posted by Michael Wonder on 21 Oct 2022
Pfizer COVID vaccine price hike to boost revenue for years, rivals may follow
21 October 2022 - Pfizer's plan to as much as quadruple US prices for its COVID-19 vaccine next year is ...
Posted by Michael Wonder on 20 Oct 2022
US FDA grants emergency use authorisation for Novavax COVID-19 Vaccine, adjuvanted as a booster for adults
19 October 2022 - Novavax today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorisation from the ...
Posted by Michael Wonder on 17 Oct 2022
US FDA approves Menveo in a new single vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W
17 October 2022 - Single vial presentation option removes the need for reconstitution of Menveo before use in individuals 10 ...
Posted by Michael Wonder on 12 Oct 2022
FDA authorises Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose in younger age groups
12 October 2022 - Today, the US FDA amended the emergency use authorisations of the Moderna COVID-19 Vaccine, Bivalent and the ...
Posted by Michael Wonder on 07 Oct 2022
FDA approves vaccine for use during third trimester of pregnancy to prevent whooping cough in infants younger than two months of age
7 October 2022 - Today, the US FDA approved Boostrix (Tetanus toxoid, reduced Diphtheria toxoid and acellular Pertussis vaccine, adsorbed) for ...
Posted by Michael Wonder on 26 Sep 2022
Pfizer and BioNTech submit application to U.S. FDA for Emergency Use Authorisation of Omicron BA.4/BA.5 adapted bivalent vaccine booster in children 5 through 11 years of age
26 September 2022 - Pfizer and BioNTech today announced they have completed a submission to the US FDA requesting Emergency Use ...
Posted by Michael Wonder on 24 Sep 2022
Moderna asks FDA to authorise omicron Covid boosters for children as young as 6 years old
23 September 2022 - The Centers for Disease Control and Prevention, in a document published Tuesday, said it expects children to ...
Posted by Michael Wonder on 07 Sep 2022
Statement by President Biden on FDA and CDC authorising updated COVID-19 vaccines
6 September 2022 - This week, we begin a new phase in our COVID-19 response. We are launching a new ...
Posted by Michael Wonder on 07 Sep 2022
FDA grants breakthrough therapy designation to Pfizer’s Group B Streptococcus vaccine candidate to help prevent infection in infants via immunisation of pregnant women
7 September 2022 - Pfizer today announced that its investigational Group B Streptococcus vaccine candidate, GBS6 or PF-06760805, received breakthrough ...