financetom
Business
financetom
/
Business
/
Invivyd Urges US FDA to Focus on Monoclonal Antibodies for COVID-19 Prevention, Re-Assess Vaccine Efficacy
News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities
Invivyd Urges US FDA to Focus on Monoclonal Antibodies for COVID-19 Prevention, Re-Assess Vaccine Efficacy
May 26, 2025 7:40 AM

08:35 AM EDT, 05/14/2025 (MT Newswires) -- Invivyd ( IVVD ) said Wednesday that it has urged the US Food and Drug Administration to focus on monoclonal antibodies for the prevention of COVID-19 to rebuild Americans' trust in scientific data and public health recommendations.

The company said the citizen petition it filed with the FDA requested a re-evaluation of COVID-19 mRNA vaccines as well as new clinical trials to assess vaccine effectiveness.

Invivyd ( IVVD ) said it has also asked the US health regulator to make clear that biologics license application approval is appropriate based on serum virus neutralizing antibody titers.

The company's shares rose 7% in recent premarket activity on Wednesday.

Comments
Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
Related Articles >
ClearPoint Neuro Says FDA Granted Marketing Authorization for SmartFlow Neuro Cannula
ClearPoint Neuro Says FDA Granted Marketing Authorization for SmartFlow Neuro Cannula
Nov 14, 2024
04:54 AM EST, 11/14/2024 (MT Newswires) -- ClearPoint Neuro ( CLPT ) said late Wednesday the US Food and Drug Administration has granted de novo marketing authorization for its SmartFlow Neuro Cannula for the delivery of PTC Therapeutics' ( PTCT ) Kebilidi gene therapy to targeted regions within the brain. Kebilidi is indicated for the treatment of aromatic L-amino acid...
Etihad Airways's nine-month profit up 66% on booming passenger numbers
Etihad Airways's nine-month profit up 66% on booming passenger numbers
Nov 14, 2024
DUBAI (Reuters) - Abu Dhabi carrier Etihad Airways reported a 66% increase in net profit in the first nine months of the year, helped by a double-digit increase in passenger traffic. The state-owned airline made 1.4 billion dirhams ($381 million) as of Sept. 30, it said in a statement on Thursday, compared to 814 million dirhams in the same period...
Burberry puts focus back on trench coats in turnaround plan
Burberry puts focus back on trench coats in turnaround plan
Nov 14, 2024
LONDON (Reuters) -Burberry will use its British heritage appeal to win back customers by focusing on trench coats and scarves and be less ambitious with prices on bags and shoes, the loss-making luxury brand said in a revamp that sent its shares up sharply. New CEO Joshua Schulman laid out his turnaround plans on Thursday after Burberry reported a loss...
JD.com Q3 Adjusted Earnings, Revenue Increase
JD.com Q3 Adjusted Earnings, Revenue Increase
Nov 14, 2024
04:43 AM EST, 11/14/2024 (MT Newswires) -- JD.com ( JD ) reported Q3 adjusted earnings Thursday of 8.68 renminbi ($1.24) per diluted American depositary share, up from 6.70 renminbi a year earlier. Analysts polled by Capital IQ expected 7.49 renminbi. Revenue for the quarter ended Sept. 30 was 260.39 billion renminbi, up from 247.7 billion renminbi a year earlier. Analysts...
Copyright 2023-2026 - www.financetom.com All Rights Reserved