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RSS FeedPosted by Michael Wonder on 10 Aug 2023
New COVID-19 vaccine and booster shots for this fall to be available by end of September
9 August 2023 - The first new COVID-19 vaccines updated for this fall season are now expected to be available by ...
Posted by Michael Wonder on 03 Aug 2023
US FDA approves Merck’s Ervebo (Ebola Zaire vaccine, live) for use in children 12 months of age and older
3 August 2023 - Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease. ...
Posted by Michael Wonder on 21 Jul 2023
Emergent BioSolutions receives US FDA approval of Cyfendus (anthrax vaccine adsorbed, adjuvanted), previously known as AV7909, a two dose anthrax vaccine for post-exposure prophylaxis use
20 July 2023 - Emergent has been delivering Cyfendus vaccine to the US Department of Health and Human Services since ...
Posted by Michael Wonder on 11 Jul 2023
Takeda withdraws US application for dengue vaccine candidate
11 July 2023 - Takeda said on Tuesday it was voluntarily withdrawing its application for its dengue vaccine candidate, following ...
Posted by Michael Wonder on 27 Jun 2023
AC Immune receives FDA fast track designation for anti-amyloid beta active immunotherapy, ACI-24.060, to treat Alzheimer’s disease
27 June 2023 - Initial PET data on amyloid plaque reduction in Alzheimer's disease expected H1, 2024. ...
Posted by Michael Wonder on 27 Jun 2023
GSK receives US FDA fast track designation for investigational vaccine against gonorrhoea
27 June 2023 - Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to ...
Posted 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 01 Jun 2023
US FDA approves Abrysvo, Pfizer’s vaccine for the prevention of respiratory syncytial virus in older adults
31 May 2023 - FDA’s decision is based on the data from the pivotal Phase 3 clinical trial in approximately 37,000 ...
Posted by Michael Wonder on 03 May 2023
FDA approves first respiratory syncytial virus vaccine
3 May 2023 - Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine ...
Posted by Michael Wonder on 28 Apr 2023
US FDA approves Prevnar 20, Pfizer’s 20 valent pneumococcal conjugate vaccine for infants and children
27 April 2023 - Prevnar 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect ...
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 06 Mar 2023
US FDA approves intramuscular administration for Merck’s MMRV family of vaccines: M-M-RII (measles, mumps and rubella virus vaccine live), Varivax (varicella virus vaccine live) and ProQuad (measles, mumps, rubella and varicella virus vaccine live)
6 March 2023 - With this additional route of administration, the MMRV family now joins other routinely recommended vaccines that ...
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 ...