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FDA, Moderna and flu vaccine

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Overview
 · 50m · on MSN
Moderna says FDA refuses to review its new flu vaccine
Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent with previous feedback.

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 · 2h · on MSN
FDA won’t review Moderna application for first mRNA-based flu vaccine
 · 3h · on MSN
Moderna says FDA refuses to review its application for experimental flu shot
 · 2h
FDA refuses to review Moderna’s application for mRNA flu vaccine, company says
The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology tha...

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 · 2h
Moderna says FDA refuses its application for new mRNA flu vaccine
 · 3h
FDA Refuses to Consider Approving Use of Moderna’s New Flu Vaccine
4hon MSN

FDA reviews potentially carcinogenic BHA chemical preservative

The Food and Drug Administration is undertaking a review of the chemical preservative butylated hydroxyanisole to determine if it is safe.
14mon MSN

FDA moves to ban BHA — an additive used in processed foods such as meats and bread

The Food and Drug Administration on Tuesday took steps toward banning BHA, a food additive used in processed foods such as meats and bread
7h

FDA to reassess the safety of BHA, a preservative used in popular snack foods

Federal health officials will reassess the safety of a chemical called BHA used in foods including potato chips, cereals, frozen meals and meat products. The U.S.
Targeted Oncology
4h

FDA Approves Pembrolizumab Combo for Recurrent Ovarian Cancer

FDA approves pembrolizumab with chemotherapy for platinum-resistant ovarian cancer, showing significant survival benefits in clinical trials. The FDA has approved pembrolizumab (Keytruda) plus paclitaxel, with or without bevacizumab (Avastin) for the treatment of patients with platinum-resistant recurrent ovarian cancer. 1
MedPage Today
5h

FDA Drops Other REMS Requirements for Top Acne Medication

With clinician approval, reproductive-age patients prescribed isotretinoin-containing drugs for acne may complete required pregnancy testing at home or in other non-medical settings, the FDA announced.
1d

FDA says Novo Nordisk's TV ad for obesity pill includes 'false or misleading' claims

The FDA requested that Novo take immediate action to address the violations, which could include ceasing all ads containing misleading claims about the pill.
16h

FDA clarifies rules for “no artificial colours” food packaging claims

The US Food and Drug Administration has issued a letter outlining how it will apply enforcement discretion to voluntary “no artificial colours” labelling claims.
STAT
1d

FDA warned a Hims & Hers compounder after finding bugs and failing to report a serious side effect

FDA inspectors found a live spider and dead cricket in a facility that was compounding weight loss drugs for Hims & Hers.
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