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722,048 Results for "moderna therapeutics inc".
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COVID-19
Vinay Prasad Overruled Reviewers on Moderna’s COVID-19 Shot for Kids
In a July 9 memo, the director of the FDA’s Center for Biologics Evaluation and Research contended there was not enough evidence that the benefits of Moderna’s COVID-19 vaccine Spikevax outweighed its risks in healthy children.
July 16, 2025
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2 min read
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Tristan Manalac
Influenza
Moderna’s Promised mRNA Flu Vaccine Bests Current Standard Shot
In adults 50 and older, Moderna’s flu shot was more than 26% better than an unspecified commercial vaccine. In May, the company pulled its application for a combo flu/COVID-19 shot, saying it would refile following data from this Phase III trial.
June 30, 2025
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2 min read
·
Tristan Manalac
COVID-19
Moderna Wins Full Approval for COVID-19 Shot for Higher-Risk Kids
The approval of Moderna’s Spikevax for kids at higher risk of contracting the disease continues the company’s regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine and an RSV shot.
July 11, 2025
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2 min read
·
Tristan Manalac
Vaccines
ACIP Skips Votes on COVID and Moderna’s mRESVIA but Scrutinzes mRNA Vaccine Safety
The revamped and “more anti-vax skewed ACIP committee” at the CDC “has a bone to pick with mRNA vaccines,” according to Truist Securities analysts. Meanwhile, the FDA moves forward on having Pfizer/BioNTech and Moderna update labels for their COVID vaccines.
June 27, 2025
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2 min read
·
Jef Akst
Vaccines
After Moderna Pulled Its Shot, Combination Flu/COVID Vaccines Hang in Limbo
Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.
July 21, 2025
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7 min read
·
Dan Samorodnitsky
Vaccines
Moderna Wins FDA Approval for Next-Gen COVID-19 Vaccine Despite ‘Investor Nervousness’
Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors worried.
June 2, 2025
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3 min read
·
Nick Paul Taylor
Vaccines
FDA Asks Pfizer/BioNTech, Moderna To Add Myocarditis Risk to COVID-19 Vaccines
The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge the agency’s directive. The products’ labels already include myocarditis warnings, albeit for different age groups.
May 22, 2025
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2 min read
·
Tristan Manalac
Infectious disease
Moderna Loses $760M+ Government Bird Flu Contract as Vaccine Uncertainties Mount
The canceled contract comes as Moderna nears a critical FDA decision for its next-generation COVID-19 vaccine.
May 29, 2025
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2 min read
·
Tristan Manalac
Earnings
Moderna Misses Q1 Revenue Expectations, Plans Another $1.5B in Cuts
Jefferies analysts said Moderna’s first quarter was “in line,” with a miss on revenue offset by a beat on earnings per share.
May 1, 2025
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3 min read
·
Annalee Armstrong
Vaccines
Moderna Shares Fall as Combo Flu/COVID-19 Vaccine Application Pulled
After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy in eliciting antibodies in data announced earlier this month.
May 21, 2025
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2 min read
·
Dan Samorodnitsky
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