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RSS FeedPosted by Michael Wonder on 26 Jul 2021
Shingrix approved in the US for prevention of shingles in immunocompromised adults
26 July 2021 - GlaxoSmithKline today announced that the US FDA has approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention ...
Posted by Michael Wonder on 26 Jul 2021
Full FDA approval is needed to overcome vaccine hesitancy
26 July 2021 - As the Delta variant spreads, what is the agency waiting for? ...
Posted by Michael Wonder on 18 Jul 2021
U.S. FDA grants priority review for the biologics license application for Pfizer-BioNTech COVID-19 vaccine
16 July 2021 - Pfizer and BioNTech today announced that the U.S. FDA granted priority review designation for the biologics license ...
Posted by Michael Wonder on 17 Jul 2021
Merck announces U.S. FDA approval of Vaxneuvance (Pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes
16 July 2021 - Clinical data supporting approval demonstrated non-inferior immune responses for the serotypes shared with PCV13 (1, 3, 4, ...
Posted by Michael Wonder on 12 Jul 2021
FDA to announce new warning on J&J COVID vaccine related to a rare auto-immune disorder, report says
12 July 2021 - About 100 preliminary reports of Guillain-Barre syndrome have been detected after 12.8 million doses of the J&J ...
Posted by Michael Wonder on 12 Jul 2021
Experts warn full FDA COVID-19 vaccine approval is no quick fix for hesitancy
12 July 2021 - The FDA issuing full approval for two COVID-19 vaccines might not be the game changer it’s ...
Posted by Michael Wonder on 09 Jul 2021
Pfizer plans to request FDA approval for COVID booster shot in August
9 Jul 2021 - Pfizer plans to request US emergency authorisation in August for a third booster dose of its ...
Posted by Michael Wonder on 07 Jul 2021
Valneva awarded FDA breakthrough designation for its single-shot Chikungunya vaccine candidate
7 July 2021 - This new U.S. milestone follows FDA fast track and EMA PRIME designations. ...
Posted by Michael Wonder on 05 Jul 2021
It’s time for the FDA to fully approve the mRNA vaccines
1 July 2021 - Here’s a paradox: a new drug for Alzheimer’s disease, aducanumab, gets approved by the FDA through an ...
Posted by Michael Wonder on 15 Jun 2021
Istari Oncology announces FDA granted fast track designation to PVSRIPO for the treatment of advanced melanoma
14 June 2021 - Istari Oncology announced today the U.S. FDA has granted fast track designation to PVSRIPO for the ...
Posted by Michael Wonder on 11 Jun 2021
Moderna files for emergency use authorisation for its COVID-19 vaccine in adolescents in the United States
10 June 2021 - Submission based on Phase 2/3 trial of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 09 Jun 2021
Millions of J&J COVID-19 vaccines are at risk of expiring in June
8 June 2021 - States, hospitals try to reroute such vaccines, while efforts to export them face hurdles. ...
Posted by Michael Wonder on 09 Jun 2021
US FDA approves Prevnar 20, Pfizer’s pneumococcal 20 valent conjugate vaccine for adults ages 18 years or older
8 June 2021 - First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of ...
Posted by Michael Wonder on 08 Jun 2021
VBI Vaccines granted FDA fast track designation for VBI-1901 for the treatment of recurrent GBM
8 June 2021 - Designation granted based on data from the Phase 1/2a study of VBI-1901 in recurrent GBM patients. ...
Posted by Michael Wonder on 01 Jun 2021
Moderna announces initiation of rolling submission of biologics license application with US FDA for the Moderna COVID-19 vaccine
1 June 2021 - Moderna today announced that it has initiated the rolling submission process with the U.S. FDA for ...