Monday, June 30, 2025

June 30, 2025 at 08:29PM GAMMAGARD LIQUID

Product approval information is indicated for:
• Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
• Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

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Sunday, June 29, 2025

People Are Reporting A Frightening COVID Symptom Right Now — Here's What To Know - HuffPost

  1. People Are Reporting A Frightening COVID Symptom Right Now — Here's What To Know  HuffPost
  2. A new COVID variant is spreading in the US: What are the symptoms?  USA Today
  3. Is COVID still going around? Yes, and people are reporting ‘razor-blade throat’ as a symptom  The Desert Sun
  4. Why COVID 'Razor Blade' Sore Throat Hurts So Bad  WebMD
  5. The latest on the new COVID-19 variant and the the measles outbreak  KGUN 9


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Utah health officials report 2 new cases of measles; statewide total now 7 - KSL News

  1. Utah health officials report 2 new cases of measles; statewide total now 7  KSL News
  2. Utah families seek Measles vaccines for children early amid nationwide outbreak  FOX 13 News Utah
  3. Health department confirms two new measles cases, advises monitoring in Orem areas  KUTV
  4. More measles cases identified in Utah, including first in a child  The Salt Lake Tribune
  5. Utah's first child measles case and more on Behind the Headlines  Utah Public Radio


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Utah health officials report 2 new cases of measles; statewide total now 7 - KSL News

  1. Utah health officials report 2 new cases of measles; statewide total now 7  KSL News
  2. Utah families seek Measles vaccines for children early amid nationwide outbreak  FOX 13 News Utah
  3. Health department confirms two new measles cases, advises monitoring in Orem areas  KUTV
  4. More measles cases identified in Utah, including first in a child  The Salt Lake Tribune
  5. Utah's first child measles case and more on Behind the Headlines  Utah Public Radio


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Friday, June 27, 2025

2 more Utahns diagnosed with measles, bringing state total to 5 - KSL News

  1. 2 more Utahns diagnosed with measles, bringing state total to 5  KSL News
  2. Two more measles cases reported in Utah, total rises to five, including two pregnant women  KUTV
  3. Utah health officials report 2 new cases of measles; statewide total now 7  KSL News
  4. Utah families seek Measles vaccines for children early amid nationwide outbreak  FOX 13 News Utah
  5. More measles cases identified in Utah, including first in a child  The Salt Lake Tribune


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June 27, 2025 at 11:17PM MNEXSPIKE

For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
MNEXSPIKE is approved for use in individuals who have been previously vaccinated with any COVID-19 vaccine and are:
• 65 years of age and older, or
• 12 thro

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June 27, 2025 at 10:16PM FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

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June 27, 2025 at 08:56PM TECARTUS

For the treatment of adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL). For the treatment of adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL).

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June 27, 2025 at 07:50PM YESCARTA

For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.

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June 27, 2025 at 04:10PM ABECMA (idecabtagene vicleucel)

ABECMA is the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

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Thursday, June 26, 2025

June 27, 2025 at 01:42AM FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies

The REMS for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because the FDA has determined that a REMS is no longer necessary.

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June 26, 2025 at 03:43PM Unique Device Identifier Requirements for Combination Products

Draft guidance to assist industry and FDA staff in understanding how FDA’s unique device identifier (UDI) requirements apply to combination products with device constituent parts, and outline requirements and recommendations for UDI labeling and submission of information to the GUDID database

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June 26, 2025 at 03:42PM Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficien

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June 26, 2025 at 02:20PM mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

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Wednesday, June 25, 2025

June 25, 2025 at 09:52PM Labeling for CBER-Regulated Products

Labeling for CBER-Regulated Products

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June 25, 2025 at 07:36PM FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination

FDA has required and approved updates to the Prescribing Information for Comirnaty manufactured by Pfizer Inc. and Spikevax manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines.

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Tuesday, June 24, 2025

June 24, 2025 at 04:59PM Laboratory Information Bulletins

Laboratory Information Bulletins available to the public

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June 24, 2025 at 01:00PM Questions about Vaccines

Information on general and specific vaccines

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Sunday, June 22, 2025

‘I feel like I’ve been lied to’: When a measles outbreak hits home - The Spokesman-Review

‘I feel like I’ve been lied to’: When a measles outbreak hits home  The Spokesman-ReviewView Full Coverage on Google News

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‘I Feel Like I’ve Been Lied To’: When a Measles Outbreak Hits Home - The New York Times

  1. ‘I Feel Like I’ve Been Lied To’: When a Measles Outbreak Hits Home  The New York Times
  2. US adds 17 more measles cases as Georgia, Iowa report new infections  CIDRAP
  3. Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases  PBS
  4. Westfield Health Bulletin: Measles outbreaks highlight need for vaccination  MassLive
  5. Measles update: Five reported cases in eastern Iowa  KCRG


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‘I feel like I’ve been lied to’: When a measles outbreak hits home - The Spokesman-Review

‘I feel like I’ve been lied to’: When a measles outbreak hits home  The Spokesman-ReviewView Full Coverage on Google News

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‘I feel like I’ve been lied to’: When a measles outbreak hits home - The Spokesman-Review

‘I feel like I’ve been lied to’: When a measles outbreak hits home  The Spokesman-ReviewView Full Coverage on Google News

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‘I Feel Like I’ve Been Lied To’: When a Measles Outbreak Hits Home - The New York Times

  1. ‘I Feel Like I’ve Been Lied To’: When a Measles Outbreak Hits Home  The New York Times
  2. US adds 17 more measles cases as Georgia, Iowa report new infections  CIDRAP
  3. Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases  PBS
  4. Westfield Health Bulletin: Measles outbreaks highlight need for vaccination  MassLive
  5. Measles update: Five reported cases in eastern Iowa  KCRG


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‘I Feel Like I’ve Been Lied To’: When a Measles Outbreak Hits Home - The New York Times

  1. ‘I Feel Like I’ve Been Lied To’: When a Measles Outbreak Hits Home  The New York Times
  2. Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases  PBS
  3. US adds 17 more measles cases as Georgia, Iowa report new infections  CIDRAP
  4. Westfield Health Bulletin: Measles outbreaks highlight need for vaccination  MassLive
  5. Measles update: Five reported cases in eastern Iowa  KCRG


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Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases - PBS

  1. Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases  PBS
  2. ‘I Feel Like I’ve Been Lied To’: When a Measles Outbreak Hits Home  The New York Times
  3. US adds 17 more measles cases as Georgia, Iowa report new infections  CIDRAP
  4. Westfield Health Bulletin: Measles outbreaks highlight need for vaccination  MassLive
  5. Measles update: Five reported cases in eastern Iowa  KCRG


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Saturday, June 21, 2025

Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases - PBS

  1. Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases  PBS
  2. US adds 17 more measles cases as Georgia, Iowa report new infections  CIDRAP
  3. Westfield Health Bulletin: Measles outbreaks highlight need for vaccination  MassLive
  4. Measles update: Five reported cases in eastern Iowa  KCRG
  5. 3 new measles cases reported in eastern Iowa  KCCI


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Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases - PBS

  1. Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases  PBS
  2. US adds 17 more measles cases as Georgia, Iowa report new infections  CIDRAP
  3. DC-area pediatrician on CDC urging summer camp operators to screen for measles immunity  WTOP
  4. 3% of measles cases are among fully vaccinated individuals, CDC says  USA Today
  5. Westfield Health Bulletin: Measles outbreaks highlight need for vaccination  MassLive


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Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases - PBS

  1. Iowa announces measles outbreak as U.S. tops 1,200 confirmed cases  PBS
  2. US adds 17 more measles cases as Georgia, Iowa report new infections  CIDRAP
  3. DC-area pediatrician on CDC urging summer camp operators to screen for measles immunity  WTOP
  4. 3% of measles cases are among fully vaccinated individuals, CDC says  USA Today
  5. Urgent warning to Irish holidaymakers about measles outbreaks in European countries  The Irish Independent


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Thursday, June 19, 2025

Deadly listeria outbreak leads to recall of ready-to-eat fettuccine Alfredo meals - NPR

  1. Deadly listeria outbreak leads to recall of ready-to-eat fettuccine Alfredo meals  NPR
  2. Deaths, pregnancy loss linked to recalled pasta sold at Walmart and Kroger  Fox Business
  3. 3 Dead in Listeria Outbreak Tied to Chicken Pasta Sold at Walmart and Kroger  The New York Times
  4. USDA Announces Recall on Ready-To-Eat Product Sold at Walmart Linked to Deadly Listeria Outbreak  Allrecipes
  5. Where People Got Sick: Chicken Fettuccine Alfredo Meals Outbreak, June 2025  Centers for Disease Control and Prevention | CDC (.gov)


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Deadly listeria outbreak leads to recall of ready-to-eat fettuccine Alfredo meals - NPR

  1. Deadly listeria outbreak leads to recall of ready-to-eat fettuccine Alfredo meals  NPR
  2. Deaths, pregnancy loss linked to recalled pasta sold at Walmart and Kroger  Fox Business
  3. USDA Announces Recall on Ready-To-Eat Product Sold at Walmart Linked to Deadly Listeria Outbreak  Allrecipes
  4. Chicken Alfredo meals at Walmart and Kroger recalled after 3 deaths, 16 hospitalizations  NBC News
  5. Where People Got Sick: Chicken Fettuccine Alfredo Meals Outbreak, June 2025  Centers for Disease Control and Prevention | CDC (.gov)


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Chicken Alfredo meals at Walmart and Kroger recalled after 3 deaths, 16 hospitalizations - NBC News

  1. Chicken Alfredo meals at Walmart and Kroger recalled after 3 deaths, 16 hospitalizations  NBC News
  2. Deaths, pregnancy loss linked to recalled pasta sold at Walmart and Kroger  Fox Business
  3. Deadly listeria outbreak leads to recall of ready-to-eat fettuccine Alfredo meals  NPR
  4. 3 Dead in Listeria Outbreak Tied to Chicken Pasta Sold at Walmart and Kroger  The New York Times
  5. USDA Announces Recall on Ready-To-Eat Product Sold at Walmart Linked to Deadly Listeria Outbreak  Allrecipes


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Wednesday, June 18, 2025

June 18, 2025 at 04:17PM PRIVIGEN

For the treatment of:

Primary humoral immunodeficiency (PI)

Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older

Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

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Monday, June 16, 2025

Outbreak fears at Dulles International Airport as passenger with world's most infectious disease triggers alert - Daily Mail

  1. Outbreak fears at Dulles International Airport as passenger with world's most infectious disease triggers alert  Daily Mail
  2. VDH reports potential measles exposure in Northern Virginia, D.C. area  InsideNoVa.com
  3. Health officials warn of measles case from traveler at Dulles Airport  The Washington Post
  4. DC health officials confirm case of measles  WTOP
  5. Health officials track more travel-linked measles exposures across US  CIDRAP


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Outbreak fears at Dulles International Airport as passenger with world's most infectious disease triggers alert - Daily Mail

  1. Outbreak fears at Dulles International Airport as passenger with world's most infectious disease triggers alert  Daily Mail
  2. VDH reports potential measles exposure in Northern Virginia, D.C. area  InsideNoVa.com
  3. Health officials track more travel-linked measles exposures across US  CIDRAP
  4. Health officials warn of measles case from traveler at Dulles Airport  The Washington Post
  5. DC health officials confirm case of measles  WTOP


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Outbreak fears at Dulles International Airport as passenger with world's most infectious disease triggers alert - dailymail.co.uk

  1. Outbreak fears at Dulles International Airport as passenger with world's most infectious disease triggers alert  dailymail.co.uk
  2. VDH reports potential measles exposure in Northern Virginia, D.C. area  InsideNoVa.com
  3. Health officials track more travel-linked measles exposures across US  CIDRAP
  4. Health officials warn of measles case from traveler at Dulles Airport  The Washington Post
  5. DC health officials confirm case of measles  WTOP


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Outbreak fears at Dulles International Airport as passenger with world's most infectious disease triggers alert - Daily Mail

  1. Outbreak fears at Dulles International Airport as passenger with world's most infectious disease triggers alert  Daily Mail
  2. Health officials warn of measles case from traveler at Dulles Airport  The Washington Post
  3. VDH reports potential measles exposure in Northern Virginia, D.C. area  InsideNoVa.com
  4. Passenger with measles arrived at Dulles and took Metro, DC Health warns  NBC4 Washington
  5. DC health officials confirm case of measles  WTOP


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Saturday, June 14, 2025

US measles count nears 1,200 cases as Ohio officials confirm 3 outbreaks are over - AP News

US measles count nears 1,200 cases as Ohio officials confirm 3 outbreaks are over  AP NewsView Full Coverage on Google News

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US measles count nears 1,200 cases as Ohio officials confirm 3 outbreaks are over - AP News

US measles count nears 1,200 cases as Ohio officials confirm 3 outbreaks are over  AP NewsView Full Coverage on Google News

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US measles count nears 1,200 cases as Ohio officials confirm 3 outbreaks are over - AP News

US measles count nears 1,200 cases as Ohio officials confirm 3 outbreaks are over  AP NewsView Full Coverage on Google News

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US measles count nears 1,200 cases as Ohio officials confirm 3 outbreaks are over - AP News

US measles count nears 1,200 cases as Ohio officials confirm 3 outbreaks are over  AP NewsView Full Coverage on Google News

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Friday, June 13, 2025

June 13, 2025 at 06:15PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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June 13, 2025 at 02:48PM FDA Rare Disease Innovation Hub

FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.

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Thursday, June 12, 2025

June 12, 2025 at 09:24PM 2025 Biological License Application Approvals

Listing of the 2025 Biological License Application Approvals

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June 12, 2025 at 04:34PM Compliance Programs (CBER)

List of biological CBER compliance programs

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Tuesday, June 10, 2025

Arizona officials confirm measles outbreak in Navajo County - AP News

  1. Arizona officials confirm measles outbreak in Navajo County  AP News
  2. The West Texas measles outbreak has started to slow for the first time since January  Texas Standard
  3. Measles outbreaks in Michigan and Pennsylvania end, while Texas logs just 4 new cases  huntingdondailynews.com
  4. Measles outbreak: 744 cases reported across the South Plains  KLBK
  5. Texas measles outbreak 2025: 2 new cases reported as state reduces number of 'outbreak counties'  FOX 4 News Dallas-Fort Worth


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Measles outbreaks in Michigan and Pennsylvania end, while Texas logs just 4 new cases - AP News

Measles outbreaks in Michigan and Pennsylvania end, while Texas logs just 4 new cases  AP NewsView Full Coverage on Google News

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Measles outbreaks in Michigan and Pennsylvania end, while Texas logs just 4 new cases - AP News

Measles outbreaks in Michigan and Pennsylvania end, while Texas logs just 4 new cases  AP NewsView Full Coverage on Google News

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Measles outbreaks in Michigan and Pennsylvania end, while Texas logs just 4 new cases - AP News

  1. Measles outbreaks in Michigan and Pennsylvania end, while Texas logs just 4 new cases  AP News
  2. Texas measles outbreak 2025: 2 new cases reported as state reduces number of 'outbreak counties'  FOX 4 News Dallas-Fort Worth
  3. CDC: MEASLES OUTBREAK IN PA IS OVER  wccsradio.com
  4. Measles update: Health officials link 2 more cases to West Texas outbreak  Texas Public Radio | TPR
  5. How measles tore through a remote West Texas city  NBC News


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June 10, 2025 at 04:29PM ABRYSVO

ABRYSVO is an active immunization for the prevention of LRTD caused by RSV

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June 10, 2025 at 02:55PM Seasonal Information for Influenza Virus Vaccine

Seasonal Information for Influenza Virus Vaccine

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Saturday, June 7, 2025

Measles cases see biggest rise in over a month - The Hill

  1. Measles cases see biggest rise in over a month  The Hill
  2. US measles cases nearing 30-year high  ABC News
  3. Warning of overseas outbreaks, CDC urges Americans to get the measles vaccine before traveling abroad  NBC News
  4. More measles exposures are happening at airports and tourist destinations. Here’s what travelers need to know  CNN
  5. What’s behind CDC’s latest measles warning to international travelers  WTOP


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At least 1.7 million eggs recalled as CDC and FDA investigate multistate salmonella outbreak - NBC News

  1. At least 1.7 million eggs recalled as CDC and FDA investigate multistate salmonella outbreak  NBC News
  2. Salmonella Outbreak Linked to Eggs  Centers for Disease Control and Prevention | CDC (.gov)
  3. Salmonella outbreak linked to eggs sickens dozens of people across 7 states  CNN
  4. Egg Recall Map Shows Warnings Issued to Customers in 9 States  Newsweek
  5. Outbreak Investigation of Salmonella: Eggs (June 2025)  fda.gov


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Measles cases see biggest rise in over a month - The Hill

  1. Measles cases see biggest rise in over a month  The Hill
  2. US measles cases nearing 30-year high  ABC News
  3. Warning of overseas outbreaks, CDC urges Americans to get the measles vaccine before traveling abroad  NBC News
  4. More measles exposures are happening at airports and tourist destinations. Here’s what travelers need to know  CNN
  5. What’s behind CDC’s latest measles warning to international travelers  WTOP


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Friday, June 6, 2025

Measles warning to holidaymakers as cases rise across Europe - BBC

  1. Measles warning to holidaymakers as cases rise across Europe  BBC
  2. Measles outbreaks continue with risk of holidays causing surge  GOV.UK
  3. Health chiefs' urgent warning over record highs of deadly measles - are YOU in a hotspot?  Daily Mail
  4. Urgent warning over deadly brain swelling disease in holiday hotspots - as health chiefs fear surge in the UK  The Sun
  5. Victorian disease UK health warning as 'too many' children at risk this summer  The Mirror


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US measles cases nearing 30-year high - ABC News

  1. US measles cases nearing 30-year high  ABC News
  2. Measles cases see biggest rise in over a month  The Hill
  3. US measles total jumps by 80, fueled by travel and more outbreaks  CIDRAP
  4. WHO sounds the alarm as US measles cases mount  Politico
  5. Opinion: How to fight measles outbreaks in NY  City & State New York


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Toilets could reveal early warning signs of a measles outbreak - WRAL.com

  1. Toilets could reveal early warning signs of a measles outbreak  WRAL.com
  2. Wastewater is now helping track measles spread around the US  CNN
  3. California has more than a dozen confirmed cases of measles so far in 2025  CBS News
  4. West Sacramento resident diagnosed with measles. Others may have been exposed  Sacramento Bee
  5. Measles Is Now Showing Up in Wastewater  Time Magazine


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Measles warning to holidaymakers as cases rise across Europe - BBC

  1. Measles warning to holidaymakers as cases rise across Europe  BBC
  2. Health chiefs' urgent warning over record highs of deadly measles - are YOU in a hotspot?  Daily Mail
  3. Victorian disease UK health warning as 'too many' children at risk this summer  The Mirror
  4. Ongoing measles outbreaks could surge in summer, UKHSA warns  Pulse Today
  5. Warning over measles risk during school holidays  The Telegraph


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Measles warning to holidaymakers as cases rise across Europe - BBC

  1. Measles warning to holidaymakers as cases rise across Europe  BBC
  2. Health chiefs' urgent warning over record highs of deadly measles - are YOU in a hotspot?  Daily Mail
  3. Urgent warning over deadly brain swelling disease in holiday hotspots - as health chiefs fear surge in the UK  The Sun
  4. Ongoing measles outbreaks could surge in summer, UKHSA warns  Pulse Today
  5. Victorian disease UK health warning as 'too many' children at risk this summer  The Mirror


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