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Top 6 u.s. food and drug administration News Today

#1
FDA refuses to review Moderna’s mRNA flu vaccine application
#1 out of 6666.3K est. views4.76%
health11h ago

FDA refuses to review Moderna’s mRNA flu vaccine application

https://www.foxnews.com/health/fda-refuses-review-modernas-mrna-flu-vaccine-applicationhttps://www.theguardian.com/us-news/2026/feb/10/fda-moderna-flu-vaccinehttps://www.cnn.com/2026/02/10/health/fda-moderna-mrna-flu-vaccine
Foxnews.com and 5 more
  • The FDA rejected Moderna’s flu vaccine application because the trial did not compare to the best-available standard of care in the United States.
  • The FDA pointed to 2024 guidance Moderna did not follow, which affected the trial design’s adequacy.
  • Moderna argues the study included comparisons to a high-dose senior shot and standard vaccines for those under 65 to show broad applicability.
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#2
The ‘No Artificial Colors’ Label You Rely On Just Changed — Here’s What the FDA Now Allows
#2 out of 698.12%
health1h ago

The ‘No Artificial Colors’ Label You Rely On Just Changed — Here’s What the FDA Now Allows

https://www.foodandwine.com/fda-redefines-no-artificial-colors-label-11903801
Foodandwine.com
  • The FDA now allows the label 'no artificial colors' on foods with natural-source colorings, as long as there are no petroleum-based colors.
  • The change expands color options, including beetroot red and spirulina extract, to help replace synthetic dyes like Red 40, Yellow 5, and Blue 1.
  • Critics warn the policy could mislead shoppers by associating 'no artificial colors' with natural dyes even when synthetics are used.
  • Consumer advocates say the policy bypassed public comment and traditional regulatory channels, drawing regulatory scrutiny.
  • The policy change follows industry efforts to remove synthetic dyes and broader state considerations on banning artificial colors.
  • FDA notes the front-label claim now refers to the color source, not the absence of color itself.
  • In response to reformulations, states are considering bans while leading brands pledge to remove synthetic dyes by 2026–2027.
  • More than 20 states are reviewing or considering legislation to ban or restrict artificial dyes.
  • Shoppers should review ingredient lists to identify color additives, as the label alone may be misleading.
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#3
The FDA ad crackdown has pharma's attention. But companies aren't 'radically changing course' — yet
#3 out of 6
business1d ago

The FDA ad crackdown has pharma's attention. But companies aren't 'radically changing course' — yet

https://endpoints.news/despite-fdas-crackdown-pharma-is-still-spending-millions-on-ads/
Endpoints.news
  • Pharma firms continue heavy advertising spending even after the FDA crackdown.
  • Regulators pushed a strict ad enforcement, but industry response has not radically changed.
  • The report cites Endpoints News as the source for campaign details and context.
  • Market observers note sustained pharma ad volumes amid regulatory pressure.
  • The piece mentions the push-and-pull between regulation and industry spending.
  • Readers are directed toward premium access to read the full Endpoints article.
  • The report is categorized under pharma marketing and drug development topics.
  • The article appears in the trend section alongside other biomedical topics.
  • The piece references a broader executive and corporate hiring context in biomedicine.
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#4
Petition asks FDA to name companies linked to outbreaks
#4 out of 6
health1d ago

Petition asks FDA to name companies linked to outbreaks

https://www.foodsafetynews.com/2026/02/petition-asks-fda-to-name-companies-linked-to-outbreaks/https://www.food-safety.com/articles/11119-fda-petitioned-to-stop-protecting-identity-of-companies-involved-in-foodborne-illness-outbreaks
Foodsafetynews.com and 1 more
  • STOP Foodborne Illness has petitioned the FDA to publicly disclose all companies linked to foodborne illness outbreaks, arguing for greater transparency beyond recalls.
  • The petition argues that labeling company names as confidential commercial information (CCI) conflicts with statutory language and case law surrounding public health disclosure.
  • Legal precedent suggests confidential information must be kept private unless there is assurance of secrecy; the petition urges FDA to reinterpret or revise its stance on disclosure.
  • The petition frames disclosure as a public health duty, aligning agency practice with the administration’s push for ‘radical transparency.’
  • The new reference details that FDA could disclose names by policy change or by updating 21 CFR 20.91 to broaden brand-name disclosure.
  • Disclosing all involved companies could alert consumers, prompt reporting, and incentivize better safety practices among producers.
  • The issue is presented as a policy and transparency debate, not a critique of a single outbreak case.
  • Produce outbreaks are highlighted as an area where disclosure could have disproportionate public health impact due to perishability and recall timing.
  • The reference provides a concrete 2024 multistate E. coli romaine outbreak example where the company was not named due to lack of recall.
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#5
REGENXBIO Inc Receives FDA Complete Response Letter for RGX-121
#5 out of 6
business23h ago

REGENXBIO Inc Receives FDA Complete Response Letter for RGX-121

https://www.tradingview.com/news/tradingview:ccac44ff73752:0-regenxbio-inc-receives-fda-complete-response-letter-for-rgx-121/
Tradingview.com
  • FDA issues a Complete Response Letter to REGENXBIO for RGX-121, prompting a BLA resubmission plan.
  • FDA concerns include study criteria and surrogate endpoints guiding the CRL scope.
  • REGENXBIO plans collaboration with the FDA to resubmit the BLA for RGX-121.
  • Company aims to clarify patient population and data ahead of next regulatory steps.
  • RGX-121 has multiple FDA designations for rare diseases, supporting potential prioritization.
  • REGENXBIO disclosed the CRL in the context of its February 9, 2026 filing.
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#6
BioCardia, Inc. Completes Pre-Submission for FDA Approval of Helix Catheter
#6 out of 6
health19h ago

BioCardia, Inc. Completes Pre-Submission for FDA Approval of Helix Catheter

https://www.tradingview.com/news/tradingview:19365de907b41:0-biocardia-inc-completes-pre-submission-for-fda-approval-of-helix-catheter/
Tradingview.com
  • BioCardia says it completed a FDA Pre-Submission for its Helix Transendocardial Delivery Catheter, a key regulatory milestone.
  • Helix aims to be the first approved transendocardial delivery system in the US, according to the report.
  • The Pre-Submission includes data from 15 clinical trials for cardiac therapy delivery.
  • A U.S. FDA decision could streamline future cell therapy approvals for heart conditions.
  • Helix is described as offering superior retention and safety over other delivery methods.
  • A market clearance submission may follow within about 45 days.
  • The update was reported in TradingView’s coverage of BioCardia’s regulatory milestone.
  • The Helix Catheter is intended for transendocardial delivery in cardiac therapies.
  • BioCardia’s regulatory step aligns with broader goals for heart-condition treatments.
  • The report notes the potential for future cell therapy approvals following Helix’s progress.
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