More than 2,000 measles cases reported in the US this year as ongoing outbreaks threaten elimination status - CNN

1. More than 2,000 measles cases reported in the US this year as ongoing outbreaks threaten elimination status  CNN
2. U.S. measles cases reach highest level in over 30 years, CDC reports  Axios
3. They Were Part of the Biggest Measles Outbreak in a Generation  The New York Times
4. US measles outbreak tops 2,000 known infections  CIDRAP
5. US measles cases surpass 2,000, highest in 30 years: CDC  ABC News

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US measles cases surpass 2,000, highest in 30 years: CDC - ABC News

1. US measles cases surpass 2,000, highest in 30 years: CDC  ABC News
2. U.S. measles cases reach highest level in over 30 years, CDC reports  Axios
3. More than 2,000 measles cases reported in the US this year as ongoing outbreaks threaten elimination status  CNN
4. They Were Part of the Biggest Measles Outbreak in a Generation  The New York Times
5. The year measles came back  Vox

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Groundbreaking robotic surgery, Alzheimer's blood test: 7 of the biggest medical breakthroughs in 2025 - ABC News

1. Groundbreaking robotic surgery, Alzheimer's blood test: 7 of the biggest medical breakthroughs in 2025  ABC News
2. The top medical advances of 2025  statnews.com
3. Year in review: The standout health stories of 2025, from measles outbreaks to AI-made viruses  Live Science
4. 10 Big Moments for Medtech in 2025  Medical Device and Diagnostic industry
5. 2025’s Top 10 Research Horizons Stories: Breakthroughs, Tributes, and Hope  Research Horizons

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Superbug hits 27 states: Here’s where the deadly fungus is spreading - Yahoo News Canada

1. Superbug hits 27 states: Here’s where the deadly fungus is spreading  Yahoo News Canada
2. What is the super bug is spreading across half of the US?  The Independent
3. Candida auris spreads globally as drug resistance and virulence increase, review finds  Medical Xpress
4. A Deadly, Drug-Resistant Fungus Threatens People Around the World, Scientists Warn  Gizmodo
5. Candidozyma (Candida) auris news in Illinois  Outbreak News Today

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New measles cases in South Carolina put U.S. on the verge of losing elimination status - NBC News

1. New measles cases in South Carolina put U.S. on the verge of losing elimination status  NBC News
2. US measles cases surpass 2,000, highest in 30 years: CDC  ABC News
3. US measles outbreak tops 2,000 known infections  CIDRAP
4. State health agency urging South Carolina residents to get updated vaccines  WIS News 10
5. US measles cases surpass 2,000 this year  The Hill

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As Measles Cases Top 2,000, the U.S. Is on Brink of Losing Its Elimination Status - Gizmodo

1. As Measles Cases Top 2,000, the U.S. Is on Brink of Losing Its Elimination Status  Gizmodo
2. Here's Where Measles Case Counts Are Highest  MedPage Today
3. US measles cases surpass 2,000, highest in 30 years: CDC  ABC News
4. More measles in South Carolina imperils U.S. elimination status  NBC News
5. US measles outbreak tops 2,000 known infections  CIDRAP

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Groundbreaking robotic surgery, Alzheimer's blood test: 7 of the biggest medical breakthroughs in 2025 - ABC News

1. Groundbreaking robotic surgery, Alzheimer's blood test: 7 of the biggest medical breakthroughs in 2025  ABC News
2. 5 breakthrough health innovations in 2025  Popular Science
3. Year in review: The standout health stories of 2025, from measles outbreaks to AI-made viruses  Live Science
4. 2025’s Top 10 Research Horizons Stories: Breakthroughs, Tributes, and Hope  Research Horizons
5. Gustavo Monnerat: Nature Biotechnology Editorial on the Most Impactful Advances in Biotechnology in 2025  Oncodaily

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Groundbreaking robotic surgery, Alzheimer's blood test: 7 of the biggest medical breakthroughs in 2025 - ABC News

1. Groundbreaking robotic surgery, Alzheimer's blood test: 7 of the biggest medical breakthroughs in 2025  ABC News
2. 5 breakthrough health innovations in 2025  Popular Science
3. Year in review: The standout health stories of 2025, from measles outbreaks to AI-made viruses  Live Science
4. 6 Amazing Medical Breakthroughs Marking 2025.. Discover Them  وكالة صدى نيوز
5. World medical breakthroughs in 2025: A year in review  Qazinform

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December 29, 2025 at 07:16PM Biological Product Deviation Reports Annual Summaries

Biological Product Deviation Reports Annual Summaries

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‘Super flu’ cases rising across US: What to know - NewsNation

1. ‘Super flu’ cases rising across US: What to know  NewsNation
2. Bad flu season getting worse; skyrocketing cases set state record  USA Today
3. Tamiflu isn’t the only flu treatment available. These other options may fly under the radar – and provide relief  CNN
4. Flu patients describe 'horrible' symptoms amid New York state's record-breaking outbreak  13wham.com
5. Flu cases surge to record levels across New York state  Spectrum News NY1

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Faithful return to Bethlehem and Pope Leo XIV celebrates his first Christmas Eve Mass at St. Peter's - AP News

1. Faithful return to Bethlehem and Pope Leo XIV celebrates his first Christmas Eve Mass at St. Peter's  AP News
2. Palestinians mark Christmas in Bethlehem while navigating life during conflict  PBS
3. First Christmas in Gaza in two years: A story of hope and survival  Al Jazeera
4. Gaza’s Christians, battered by war, celebrate first Christmas in 3 years  The Washington Post
5. Bethlehem sees full Christmas revelry for first time since outbreak of Gaza war  The Times of Israel

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Bethlehem sees full Christmas revelry for first time since outbreak of Gaza war - The Times of Israel

1. Bethlehem sees full Christmas revelry for first time since outbreak of Gaza war  The Times of Israel
2. ‘No true sense of celebration’ as Israeli bombs drown out Christmas in Gaza  Al Jazeera
3. Palestinians mark Christmas in Bethlehem while navigating life during conflict  PBS
4. Gaza’s Christians, battered by war, celebrate first Christmas in 3 years  The Washington Post
5. Thousands attend Christmas tree lighting ceremony in Bethlehem, the first since war in Gaza began  CBS News

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A Grim Measles Milestone - The Dispatch

1. A Grim Measles Milestone  The Dispatch
2. DPH: 249 people quarantined, seven in isolation after new measles cases  WYFF News 4
3. Measles outbreaks won't end in 2025 as cases mount in Utah, Arizona and South Carolina  NBC News
4. Ripple by The Washington Post  The Washington Post
5. Here's Where Measles Case Counts Are Highest  MedPage Today

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A Grim Measles Milestone - The Dispatch

1. A Grim Measles Milestone  The Dispatch
2. South Carolina now has 156 measles cases, as states see highest activity in 30 years  CIDRAP
3. DPH: 249 people quarantined, seven in isolation after new measles cases  WYFF News 4
4. Measles outbreaks won't end in 2025 as cases mount in Utah, Arizona and South Carolina  NBC News
5. Here's Where Measles Case Counts Are Highest  MedPage Today

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A Grim Measles Milestone - The Dispatch

1. A Grim Measles Milestone  The Dispatch
2. DPH: 249 people quarantined, seven in isolation after new measles cases  WYFF News 4
3. SC measles outbreak surpasses 150 cases, most unvaccinated  WLOS
4. Measles outbreaks won't end in 2025 as cases mount in Utah, Arizona and South Carolina  NBC News
5. Here's Where Measles Case Counts Are Highest  MedPage Today

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A Grim Measles Milestone - The Dispatch

1. A Grim Measles Milestone  The Dispatch
2. DPH: 249 people quarantined, seven in isolation after new measles cases  WYFF News 4
3. SC measles outbreak surpasses 150 cases, most unvaccinated  WLOS
4. Measles outbreaks won't end in 2025 as cases mount in Utah, Arizona and South Carolina  NBC News
5. Here's Where Measles Case Counts Are Highest  MedPage Today

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A Grim Measles Milestone - The Dispatch

1. A Grim Measles Milestone  The Dispatch
2. SC measles outbreak surpasses 150 cases, most unvaccinated  WLOS
3. DPH: 249 people quarantined, seven in isolation after new measles cases  WYFF News 4
4. Measles outbreaks won't end in 2025 as cases mount in Utah, Arizona and South Carolina  NBC News
5. Here's Where Measles Case Counts Are Highest  MedPage Today

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A Grim Measles Milestone - The Dispatch

1. A Grim Measles Milestone  The Dispatch
2. Here's Where Measles Case Counts Are Highest  MedPage Today
3. SC measles outbreak surpasses 150 cases, most unvaccinated  WPDE
4. DPH: 249 people quarantined, seven in isolation after new measles cases  WYFF News 4
5. Measles outbreaks won't end in 2025 as cases mount in Utah, Arizona and South Carolina  NBC News

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December 23, 2025 at 04:13PM MTS Anti-IgG, -C3d Card

Indicated For in vitro blood banking reagent

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December 23, 2025 at 12:47AM Adverse Events and Product Deviation Guidances

This page lists Adverse Events and Product Deviation Guidance documents.

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December 22, 2025 at 05:57PM Devices Guidances

This page lists Medical Device Guidance documents.

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December 22, 2025 at 04:41PM Coagulation Factor Xa (Recombinant), Inactivated-ZHZO

Coagulation Factor Xa (Recombinant), Inactivated-ZHZO

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December 22, 2025 at 04:27PM Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic

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Deck the halls with masks and sanitizer: NYC’s flu outbreak could hamper holiday plans - Gothamist

1. Deck the halls with masks and sanitizer: NYC’s flu outbreak could hamper holiday plans  Gothamist
2. With cases on the rise, experts worry the U.S. is in for another bad flu season  NPR
3. Flu, Covid and RSV ‘tripledemic' lead to surge in hospitalizations on Long Island  NBC New York
4. Doctors warn about the rise of flu, COVID and RSV ahead of holiday season  News 12
5. Flu cases surge ahead of last year's level on LI  Newsday

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Deck the halls with masks and sanitizer: NYC’s flu outbreak could hamper holiday plans - Gothamist

1. Deck the halls with masks and sanitizer: NYC’s flu outbreak could hamper holiday plans  Gothamist
2. With cases on the rise, experts worry the U.S. is in for another bad flu season  NPR
3. Flu, Covid and RSV ‘tripledemic' lead to surge in hospitalizations on Long Island  NBC New York
4. Doctors warn about the rise of flu, COVID and RSV ahead of holiday season  News 12
5. Flu cases surge ahead of last year's level on LI  Newsday

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Deck the halls with masks and sanitizer: NYC’s flu outbreak could hamper holiday plans - Gothamist

1. Deck the halls with masks and sanitizer: NYC’s flu outbreak could hamper holiday plans  Gothamist
2. With cases on the rise, experts worry the U.S. is in for another bad flu season  NPR
3. Flu, Covid and RSV ‘tripledemic' lead to surge in hospitalizations on Long Island  NBC New York
4. Flu cases surge ahead of last year's level on LI  Newsday
5. Flu Cases Skyrocket in New York City, Earlier Than Expected  The New York Times

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Deck the halls with masks and sanitizer: NYC’s flu outbreak could hamper holiday plans - Gothamist

1. Deck the halls with masks and sanitizer: NYC’s flu outbreak could hamper holiday plans  Gothamist
2. Flu cases surge ahead of last year's level on LI  Newsday
3. Doctors warn about the rise of flu, COVID and RSV ahead of holiday season  News 12 - New Jersey
4. NYC flu cases surge, particularly among children: Data  PIX11
5. Flu Cases Skyrocket in New York City, Earlier Than Expected  The New York Times

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December 19, 2025 at 11:07PM ITVISMA

For the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene.

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December 18, 2025 at 09:28PM Coagulation Factor VIIa (Recombinant) - JNCW

Coagulation Factor VIIa (Recombinant) - JNCW

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SC measles outbreak could soon reach Charlotte, health director warns - Charlotte Observer

1. SC measles outbreak could soon reach Charlotte, health director warns  Charlotte Observer
2. Measles outbreaks worsen in South Carolina, Arizona and Utah  CBS News
3. Measles outbreaks won't end in 2025 as cases mount in Utah, Arizona and South Carolina  NBC News
4. US hot spots see more measles cases as national total nears 2,000  CIDRAP
5. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times

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Measles outbreaks won't end in 2025 as cases mount in Utah, Arizona and South Carolina - NBC News

1. Measles outbreaks won't end in 2025 as cases mount in Utah, Arizona and South Carolina  NBC News
2. SC measles outbreak could soon reach Charlotte, health director warns  Charlotte Observer
3. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
4. US hot spots see more measles cases as national total nears 2,000  CIDRAP
5. Measles cases are surging across the US. Experts are blaming the nation’s anti-vaccine push  The Independent

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SC measles outbreak could soon reach Charlotte, health director warns - Charlotte Observer

1. SC measles outbreak could soon reach Charlotte, health director warns  Charlotte Observer
2. US hot spots see more measles cases as national total nears 2,000  CIDRAP
3. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
4. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
5. South Carolina measles outbreak grows to 135 cases  WLOS

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December 17, 2025 at 10:26PM HIBERIX

HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).

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December 17, 2025 at 03:29PM Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

This guidance clarifies how FDA evaluates RWD to determine whether they are of sufficient quality for generating RWE for medical devices.

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Measles outbreaks worsen in South Carolina, Arizona and Utah - CBS News

1. Measles outbreaks worsen in South Carolina, Arizona and Utah  CBS News
2. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
3. SC measles outbreak could soon reach Charlotte, health director warns  Charlotte Observer
4. South Carolina measles response puts personal choice over orders  Axios
5. Upstate measles outbreak putting babies at risk  WYFF News 4

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Measles outbreaks worsen in South Carolina, Arizona and Utah - CBS News

1. Measles outbreaks worsen in South Carolina, Arizona and Utah  CBS News
2. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
3. Measles cases surging as US approaches ’embarrassing’ milestone  thehill.com
4. South Carolina measles response puts personal choice over orders  Axios
5. Upstate measles outbreak putting babies at risk  WYFF News 4

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South Carolina measles response puts personal choice over orders - Axios

1. South Carolina measles response puts personal choice over orders  Axios
2. Measles outbreaks worsen in South Carolina, Arizona and Utah  CBS News
3. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
4. Measles cases surging as US approaches ’embarrassing’ milestone  thehill.com
5. Upstate measles outbreak putting babies at risk  WYFF News 4

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December 16, 2025 at 02:55PM Vaccines Licensed for Use in the United States

The product name and trade name of vaccines licensed for use in the United States.

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South Carolina measles response puts personal choice over orders - Axios

1. South Carolina measles response puts personal choice over orders  Axios
2. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
3. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
4. South Carolina measles cases continue to climb  CIDRAP
5. Measles Outbreaks Accelerate as U.S. Inches Closer to a Disease Tipping Point  Scientific American

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Measles cases surge in US: Doctors explain how it spreads, symptoms to watch for and prevention tips to stay protected | Health - Hindustan Times

1. Measles cases surge in US: Doctors explain how it spreads, symptoms to watch for and prevention tips to stay protected | Health  Hindustan Times
2. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
3. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
4. Measles Outbreaks Accelerate as U.S. Inches Closer to a Disease Tipping Point  Scientific American
5. Measles cases surging as US approaches ’embarrassing’ milestone  thehill.com

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December 15, 2025 at 02:49PM Biologics Procedures (SOPPs)

These Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates.

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Measles cases surge in US: Doctors explain how it spreads, symptoms to watch for and prevention tips to stay protected | Health - Hindustan Times

1. Measles cases surge in US: Doctors explain how it spreads, symptoms to watch for and prevention tips to stay protected | Health  Hindustan Times
2. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
3. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
4. Hundreds Quarantined In South Carolina Measles Outbreak—What To Know About Current Cases And Its Spread  Forbes
5. Measles cases spike in South Carolina  NPR

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Hundreds Quarantined In South Carolina Measles Outbreak—What To Know About Current Cases And Its Spread - Forbes

1. Hundreds Quarantined In South Carolina Measles Outbreak—What To Know About Current Cases And Its Spread  Forbes
2. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
3. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
4. Measles cases spike in South Carolina  NPR
5. US set to lose measles elimination status: The ‘house is on fire’  thehill.com

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Hundreds Quarantined In South Carolina Measles Outbreak—What To Know About Current Cases And Its Spread - Forbes

1. Hundreds Quarantined In South Carolina Measles Outbreak—What To Know About Current Cases And Its Spread  Forbes
2. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
3. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
4. Measles cases spike in South Carolina  NPR
5. US set to lose measles elimination status: The ‘house is on fire’  thehill.com

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Hundreds Quarantined In South Carolina Measles Outbreak—What To Know About Current Cases And Its Spread - Forbes

1. Hundreds Quarantined In South Carolina Measles Outbreak—What To Know About Current Cases And Its Spread  Forbes
2. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
3. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
4. Measles cases spike in South Carolina  NPR
5. US exceeds 1,900 measles cases as outbreaks expand  CIDRAP

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A Measles Outbreak Brings With It Echoes of the Pandemic - The New York Times

1. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
2. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
3. Total number of schools exposed in Upstate measles outbreak surpasses 10  FOX Carolina
4. Hundreds Quarantined in South Carolina amid 'Accelerating' Measles Outbreak  People.com
5. South Carolina officials report ‘accelerating’ measles outbreak  The Guardian

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A Measles Outbreak Brings With It Echoes of the Pandemic - The New York Times

1. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
2. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
3. Hundreds Quarantined In South Carolina Measles Outbreak—What To Know About Current Cases And Its Spread  Forbes
4. Total number of schools exposed in Upstate measles outbreak surpasses 10  FOX Carolina
5. Hundreds Quarantined in South Carolina amid 'Accelerating' Measles Outbreak  People.com

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A Measles Outbreak Brings With It Echoes of the Pandemic - The New York Times

1. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
2. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
3. Hundreds Quarantined in South Carolina amid 'Accelerating' Measles Outbreak  People.com
4. Total number of schools exposed in Upstate measles outbreak surpasses 10  FOX Carolina
5. South Carolina officials report ‘accelerating’ measles outbreak  The Guardian

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A Measles Outbreak Brings With It Echoes of the Pandemic - The New York Times

1. A Measles Outbreak Brings With It Echoes of the Pandemic  The New York Times
2. South Carolina measles outbreak is 'accelerating,' driving hundreds into quarantine  NBC News
3. Hundreds are quarantined in South Carolina as measles spreads in 2 US outbreaks  ABC News
4. Measles Outbreaks Accelerate as U.S. Inches Closer to a Disease Tipping Point  Scientific American
5. South Carolina measles outbreak accelerates as cases rise to 126  Reuters

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Hundreds Quarantined in South Carolina Due to Measles Exposure - Bloomberg.com

1. Hundreds Quarantined in South Carolina Due to Measles Exposure  Bloomberg.com
2. Hundreds Quarantined in South Carolina as Measles Outbreak Shows No Sign of Slowing  The New York Times
3. Measles Outbreaks Accelerate as U.S. Inches Closer to a Disease Tipping Point  Scientific American
4. Total number of schools exposed in Upstate measles outbreak surpasses 10  FOX Carolina
5. South Carolina measles outbreak accelerates as cases rise to 126  Reuters

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Hundreds are quarantined in South Carolina as measles spreads in 2 US outbreaks - Yahoo

Hundreds are quarantined in South Carolina as measles spreads in 2 US outbreaks  YahooView Full Coverage on Google News

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Hundreds Quarantined in South Carolina as Measles Outbreak Shows No Sign of Slowing - The New York Times

1. Hundreds Quarantined in South Carolina as Measles Outbreak Shows No Sign of Slowing  The New York Times
2. Hundreds quarantined as South Carolina measles outbreak accelerates  The Washington Post
3. Measles Outbreaks Accelerate as U.S. Inches Closer to a Disease Tipping Point  Scientific American
4. Hundreds are quarantined in South Carolina as measles spreads in 2 US outbreaks  ABC News
5. South Carolina officials report ‘accelerating’ measles outbreak  The Guardian

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South Carolina grapples with measles outbreak - NewsNation

1. South Carolina grapples with measles outbreak  NewsNation
2. Hundreds Quarantined in South Carolina as Measles Outbreak Shows No Sign of Slowing  The New York Times
3. Hundreds quarantined as South Carolina measles outbreak accelerates  The Washington Post
4. Measles Outbreaks Accelerate as U.S. Inches Closer to a Disease Tipping Point  Scientific American
5. Hundreds are quarantined in South Carolina as measles spreads in 2 US outbreaks  ABC News

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