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FDA refuses review of mRNA flu vaccine

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Overview
 · 1d · on MSN
FDA defends its decision to not review Moderna’s mRNA flu shot
The Food and Drug Administration on Wednesday defended its rejection of Moderna’s mRNA-based flu vaccine application, saying the company’s clinical trial design put patients at risk.

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 · 1d
FDA Declines to Review Moderna’s mRNA Flu Vaccine Application
 · 1d · on MSN
Moderna says FDA refuses to review its application for experimental flu shot
 · 1d
FDA officials defend decision to not review Moderna’s new flu vaccine
Federal officials on Wednesday cast blame on Moderna as they stood by the Food and Drug Administration’s controversial decision not to review the Cambridge biotech’s new flu vaccine.

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 · 16h
FDA defends its decision to refuse review of Moderna's flu vaccine
 · 1d
Moderna says FDA won't review its mRNA flu shot | Morning in America

Novocure gets FDA approval for pancreatic cancer treatment

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 · 1d · on MSN
Novocure gets FDA approval for pancreatic cancer treatment; shares soar
The Swiss biopharmaceutical company’s shares surged in after-hours trading after it said the FDA approved its Optune Pax product.

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 · 1d
U.S. FDA Approves Novocure's Optune Pax(R) for the Treatment of Locally Advanced Pancreatic Cancer
Becker's Hospital Review · 20h
FDA clears 1st new treatment in 30 years for pancreatic cancer
2h

Peanut Butter Recall Update for 40 States as FDA Sets Risk Level

It means the products may cause temporary or medically reversible adverse health consequences, according to the FDA.
17hon MSN

US FDA approves labeling changes to menopause hormone therapies

Feb 12 (Reuters) - The U.S. Food and Drug Administration said on Thursday it has approved labeling changes to six menopause hormone therapies to remove references to risks of cardiovascular disease, breast cancer,
1d

FDA Reviews Safety of Food Preservative BHA Over Cancer Concerns

“BHA has remained in the food supply for decades despite being identified by the National Toxicology Program as ‘reasonably anticipated to be a human carcinogen’ based on animal studies,” U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr ., said.
3h

Cake Mix Recall Update as FDA Sets Most Serious Risk Level

This classification is used when the FDA finds a reasonable chance that exposure could cause serious harm or death.
3hon MSN

Eli Lilly builds $1.5 billion stockpile of weight-loss pill ahead of FDA decision

Feb 12 (Reuters) - Eli Lilly had $1.5 billion worth of pre-launch inventory of its experimental oral weight-loss drug, a filing showed on Thursday, ahead of an expected decision by the U.S. Food and Drug Administration in April.
BioSpace
16h

FDA’s Prasad Weathers Personal Controversy, Internal Strife Amid Moderna Imbroglio

Vinay Prasad, the FDA's Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.
19h

Science 37 Becomes First FDA-Inspected Site to Deliver Clinical Trials to Patients’ Homes

MORRISVILLE, NC / ACCESS Newswire / February 12, 2026 / Clinical trials are the research studies required to test the
Targeted Oncology
20h

FDA Accepts sNDA for Photodynamic Therapy in Superficial Basal Cell Carcinoma

The FDA accepted the supplemental new drug application (sNDA) for aminolevulinic acid hydrochloride 10% topical gel (Ameluz) as part of photodynamic therapy (PDT) for superficial basal cell carcinoma (sBCC). 1
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