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RSS FeedPosted by Michael Wonder on 04 Jan 2022
Novavax submits final data packages to U.S. FDA as prerequisite to Emergency Use Authorisation application request for COVID-19 Vaccine
30 December 2021 - EUA application request to be submitted following one month required by FDA EUA guidance. ...
Posted by Michael Wonder on 03 Jan 2022
FDA grants ILiAD Biotechnologies fast track designation for next generation pertussis vaccine BPZE1
3 January 2021 - ILiAD Biotechnologies, today announced that the U.S. FDA has granted fast track designation to BPZE1, a next ...
Posted by Michael Wonder on 03 Jan 2022
FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 Vaccine
3 January 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine to: ...
Posted by Michael Wonder on 18 Dec 2021
Pfizer and BioNTech submit supplemental biologics license application for U.S. FDA approval of Comirnaty in adolescents 12 through 15 years of age
16 December 2021 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the U.S. ...
Posted by Michael Wonder on 09 Dec 2021
FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16 and 17 year olds
9 December 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine, authorising the use ...
Posted by Michael Wonder on 07 Dec 2021
U.S. plans to fast track revamped COVID-19 vaccines
5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...
Posted by Michael Wonder on 01 Dec 2021
U.S. FDA accepts for priority review the supplemental biologics license application for Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 December 2021 - Merck today announced the U.S. FDA has accepted for priority review a supplemental biologics license application for ...
Posted by Michael Wonder on 01 Dec 2021
VBI Vaccines announces FDA approval of PreHevbrio for the prevention of Hepatitis B in adults
1 December 2021 - PreHevbrio is the only approved 3 antigen hepatitis B vaccine for adults in the U.S. ...
Posted by Michael Wonder on 23 Nov 2021
Seqirus announces U.S. FDA approval for multi-dose vial presentation of first ever adjuvanted, cell based pandemic influenza vaccine
23 November 2021 - The FDA has granted approval of multi-dose vial presentation for Audenz to help protect individuals six months ...
Posted by Michael Wonder on 20 Nov 2021
BioNTech receives FDA fast track designation for its FixVac candidate BNT111 in advanced melanoma
19 November 2021 - BioNTech today announced that the U.S. FDA granted fast track designation for BNT111, an investigational cancer ...
Posted by Michael Wonder on 20 Nov 2021
Moderna announces FDA authorisation of booster dose of COVID-19 vaccine in the U.S. for adults 18 years and older
19 November 2021 - Authorisation includes the use of Moderna’s booster dose following primary vaccination with other authorised or approved ...
Posted by Michael Wonder on 07 Nov 2021
Ocugen announces submission of emergency use authorisation request to the US FDA for investigational COVID-19 vaccine Covaxin (BBV152) for children ages 2-18 years
5 November 2021 - Paediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralising antibody response ...
Posted by Michael Wonder on 31 Oct 2021
FDA authorises Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age
29 October 2021 - Today, the U.S. FDA authorised the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of ...
Posted by Michael Wonder on 21 Oct 2021
Ultimovacs receives dual FDA fast track designation for UV1 in advanced malignant melanoma
21 October 2021 - UV1 as add-on therapy to checkpoint inhibitors awarded fast track designation. ...
Posted by Michael Wonder on 21 Oct 2021
FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
20 October 2021 - Today, the U.S. FDA took action to expand the use of a booster dose for COVID-19 vaccines ...