New York City declares Harlem legionnaire’s disease outbreak over - The Guardian

1. New York City declares Harlem legionnaire’s disease outbreak over  The Guardian
2. City assumes central role in Legionnaires’ outbreak as Adams vies for another term  Politico
3. In a Lab, the Hunt for a Killer: The Legionella Germ Causing an Outbreak  The New York Times
4. NYC declares Harlem Legionnaires' outbreak over, after 7th death is announced  NBC New York
5. NYC Legionnaires’ Outbreak Traced to City-Owned Sites, Including Harlem Hospital  The New York Times

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New York City declares Harlem legionnaire’s disease outbreak over - The Guardian

1. New York City declares Harlem legionnaire’s disease outbreak over  The Guardian
2. City assumes central role in Legionnaires’ outbreak as Adams vies for another term  Politico
3. NYC Legionnaires’ Outbreak Traced to City-Owned Sites, Including Harlem Hospital  The New York Times
4. Legionnaires' disease outbreak: NYC Health Department declares cluster in Harlem officially over  ABC7 New York
5. Death toll from Legionnaires' disease outbreak in New York City rises to 7 and infections hit 114  ABC News

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New York City declares Harlem legionnaire’s disease outbreak over - The Guardian

1. New York City declares Harlem legionnaire’s disease outbreak over  The Guardian
2. City assumes central role in Legionnaires’ outbreak as Adams vies for another term  Politico
3. NYC Legionnaires’ Outbreak Traced to City-Owned Sites, Including Harlem Hospital  The New York Times
4. Legionnaires' disease outbreak: NYC Health Department declares cluster in Harlem officially over  ABC7 New York
5. Death toll from Legionnaires' disease outbreak in New York City rises to 7 and infections hit 114  ABC News

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New York City declares Harlem legionnaire’s disease outbreak over - The Guardian

1. New York City declares Harlem legionnaire’s disease outbreak over  The Guardian
2. City assumes central role in Legionnaires’ outbreak as Adams vies for another term  Politico
3. NYC declares Harlem Legionnaires' outbreak over, after 7th death is announced  NBC New York
4. In a Lab, the Hunt for a Killer: The Legionella Germ Causing an Outbreak  The New York Times
5. Legionnaires' disease outbreak: NYC Health Department declares cluster in Harlem officially over  ABC7 New York

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New York City declares Harlem legionnaire’s disease outbreak over - The Guardian

1. New York City declares Harlem legionnaire’s disease outbreak over  The Guardian
2. City assumes central role in Legionnaires’ outbreak as Adams vies for another term  Politico
3. NYC declares Harlem Legionnaires' outbreak over, after 7th death is announced  NBC New York
4. In a Lab, the Hunt for a Killer: The Legionella Germ Causing an Outbreak  The New York Times
5. Legionnaires' disease outbreak: NYC Health Department declares cluster in Harlem officially over  ABC7 New York

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New York City declares Harlem legionnaire’s disease outbreak over - The Guardian

1. New York City declares Harlem legionnaire’s disease outbreak over  The Guardian
2. NYC declares Harlem Legionnaires' outbreak over, after 7th death is announced  NBC New York
3. In a Lab, the Hunt for a Killer: The Legionella Germ Causing an Outbreak  The New York Times
4. Legionnaires' disease outbreak: NYC Health Department declares cluster in Harlem officially over  ABC7 New York
5. NYC Legionnaires’ Outbreak Traced to City-Owned Sites, Including Harlem Hospital  The New York Times

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2 city buildings were origin of this summer’s NYC Legionnaires' outbreak - Gothamist

1. 2 city buildings were origin of this summer’s NYC Legionnaires' outbreak  Gothamist
2. NYC Legionnaires’ Outbreak Traced to City-Owned Sites, Including Harlem Hospital  The New York Times
3. NYC declares Harlem Legionnaires' outbreak over, after 7th death is announced  NBC New York
4. Legionnaires' disease outbreak: NYC Health Department declares cluster in Harlem officially over  ABC7 New York
5. Death toll from Legionnaires' disease outbreak in New York City rises to 7 and infections hit 114  ABC News

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NYC Legionnaires’ Outbreak Traced to City-Owned Sites, Including Harlem Hospital - The New York Times

1. NYC Legionnaires’ Outbreak Traced to City-Owned Sites, Including Harlem Hospital  The New York Times
2. NYC declares Harlem Legionnaires' outbreak over, after 7th death is announced  NBC New York
3. Legionnaires' disease outbreak: NYC Health Department declares cluster in Harlem officially over  ABC7 New York
4. Death toll from Legionnaires' disease outbreak in New York City rises to 7 and infections hit 114  ABC News
5. City assumes central role in Legionnaires’ outbreak as Adams vies for another term  Politico

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NYC Legionnaires’ Outbreak Traced to City-Owned Sites, Including Harlem Hospital - The New York Times

1. NYC Legionnaires’ Outbreak Traced to City-Owned Sites, Including Harlem Hospital  The New York Times
2. NYC declares Harlem Legionnaires' outbreak over, after 7th death is announced  NBC New York
3. Legionnaires' disease outbreak: Seventh person dies in Legionnaires' disease outbreak in Harlem as cases rise to 114  ABC7 New York
4. Death toll from Legionnaires' disease outbreak in New York City rises to 7 and infections hit 114  ABC News
5. City assumes central role in Legionnaires’ outbreak as Adams vies for another term  Politico

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Death toll from Legionnaires' disease outbreak in New York City rises to 7 and infections hit 114 - AP News

Death toll from Legionnaires' disease outbreak in New York City rises to 7 and infections hit 114  AP NewsView Full Coverage on Google News

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Salmonella Outbreak Linked to Eggs Sickens 95 People - The New York Times

1. Salmonella Outbreak Linked to Eggs Sickens 95 People  The New York Times
2. Investigation Update: Salmonella Outbreak, August 2025  Centers for Disease Control and Prevention | CDC (.gov)
3. Country Eggs recalls cage-free products in California and Nevada following salmonella outbreak  Fox Business
4. A Nationwide Salmonella Outbreak Is Affecting Mostly Californians. Here’s How to Check Your Eggs  KQED
5. LA restaurants linked to salmonella outbreak from eggs distributed in California  NBC4 Los Angeles

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In a Lab, a Hunt for a Killer: The Germ Causing a Legionnaires’ Outbreak - The New York Times

1. In a Lab, a Hunt for a Killer: The Germ Causing a Legionnaires’ Outbreak  The New York Times
2. 7th death reported in Harlem Legionnaires' disease outbreak, NYC health officials say  CBS News
3. 2 sickened with Legionnaires' at Bronx apartment complex; evaluation underway  NBC News
4. Legionnaires' disease is in the news: Here's what to know, how to spot symptoms and how to stay safe  CNBC
5. Health Tip of the Week, sponsored by Baton Rouge General: A little about Legionnaire's and the NYC outbreak  Baton Rouge Business Report

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Salmonella outbreak linked to eggs sickens 95 people, CDC says - NBC News

1. Salmonella outbreak linked to eggs sickens 95 people, CDC says  NBC News
2. Country Eggs recalls cage-free products in California and Nevada following salmonella outbreak  Fox Business
3. Investigation Update: Salmonella Outbreak, August 2025  Centers for Disease Control and Prevention | CDC (.gov)
4. CDC warns of salmonella outbreak linked to recalled eggs. What to know.  USA Today
5. Salmonella outbreak tied to recalled eggs from Country Eggs LLC in Lucerne Valley, CA sickened 95 people since January  ABC7 Los Angeles

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August 27, 2025 at 09:33PM Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine

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August 27, 2025 at 04:38PM Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Announcement - 06/15/2023

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting June 15, 2023 announcement and meeting materials.

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In a Lab, a Hunt for a Killer: The Germ Causing a Legionnaires’ Outbreak - The New York Times

1. In a Lab, a Hunt for a Killer: The Germ Causing a Legionnaires’ Outbreak  The New York Times
2. Residents ask for better communication in Bronx Legionnaires' cases  Spectrum News NY1
3. NYC health officials probing community cluster of Legionnaires' disease in Harlem  Yahoo News Canada

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Vaccine skepticism crisis spills over as students return to school - USA Today

1. Vaccine skepticism crisis spills over as students return to school  USA Today
2. ‘We are sweating’: Missouri kindergarten vaccination rates fall below immunity threshold  Missouri Independent
3. Data shows vax rates dropped in Lancaster County; outbreak risk increases  LancasterOnline
4. Cutting Through the Vaccine Noise  The Dispatch
5. Why childhood vaccination rates are dipping in Sarasota County  WUSF

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Vaccine skepticism crisis spills over as students return to school - USA Today

1. Vaccine skepticism crisis spills over as students return to school  USA Today
2. ‘We are sweating’: Missouri kindergarten vaccination rates fall below immunity threshold  Missouri Independent
3. Data shows vax rates dropped in Lancaster County; outbreak risk increases  LancasterOnline
4. Cutting Through the Vaccine Noise  The Dispatch
5. Why childhood vaccination rates are dipping in Sarasota County  WUSF

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August 26, 2025 at 03:20PM Platinum Biologics LLC - 705090 - 08/15/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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August 25, 2025 at 02:24PM FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication

On August 22, 2025,the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of

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Exclusive: U.S. confirms nation's first travel-associated human screwworm case connected to Central American outbreak - Reuters

Exclusive: U.S. confirms nation's first travel-associated human screwworm case connected to Central American outbreak  ReutersView Full Coverage on Google News

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Exclusive: U.S. confirms nation's first travel-associated human screwworm case connected to Central American outbreak - Reuters

Exclusive: U.S. confirms nation's first travel-associated human screwworm case connected to Central American outbreak  ReutersView Full Coverage on Google News

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Flesh-eating screwworm parasite detected in person in US for first time - Sky News

1. Flesh-eating screwworm parasite detected in person in US for first time  Sky News
2. Exclusive: U.S. confirms nation's first travel-associated human screwworm case connected to Central American outbreak  Reuters
3. Flesh-eating screwworm case detected in person in U.S. for 1st time in years  Axios
4. HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply  HHS.gov
5. Exclusive-First human screwworm case in US traced to person in Maryland who traveled from Guatemala, sources say  yahoo.com

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Climate Change Is Bringing Legionnaire’s Disease to a Town Near You - WIRED

1. Climate Change Is Bringing Legionnaire’s Disease to a Town Near You  WIRED
2. Legionnaires' disease outbreak: Sixth person dies in Legionnaires' disease outbreak in Harlem as cases rise to 111  ABC7 New York
3. Count this Legionnaires’ outbreak as a warning about the fecklessness of NYC government  New York Post
4. Lawsuits accuse construction companies in NYC in deadly Legionnaires outbreak  NBC News
5. Legionnaires' disease is spreading thanks to a perfect storm of conditions  USA Today

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Lawsuits accuse construction companies in NYC in deadly Legionnaires outbreak - NBC News

1. Lawsuits accuse construction companies in NYC in deadly Legionnaires outbreak  NBC News
2. Four dead in New York City outbreak of Legionnaires' disease  BBC
3. Legionnaires' disease outbreak: Sixth person dies in Legionnaires' disease outbreak in Harlem as cases rise to 111  ABC7 New York
4. This deadly bacteria was once an “only in New York” problem. Not anymore.  vox.com
5. Five deaths reported amid bacterial infection outbreak in major city  Fox News

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Europe's record mosquito-borne disease activity could signal new normal - CIDRAP

1. Europe's record mosquito-borne disease activity could signal new normal  CIDRAP
2. Mosquito-borne illnesses are at record highs in Europe, ECDC says  Euronews.com
3. Outbreaks of debilitating tropical diseases becoming Europe’s ‘new normal’  The Telegraph
4. West Nile virus, chikungunya, dengue: Tracking mosquito-borne illnesses across Europe  MSN
5. Surge in Mosquito-Borne “Suitcase Viruses” Across Europe: What Travelers Need to Know  Vocal

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Europe's record mosquito-borne disease activity could signal new normal - CIDRAP

1. Europe's record mosquito-borne disease activity could signal new normal  CIDRAP
2. Mosquito-borne illnesses are at record highs in Europe, ECDC says  Euronews.com
3. Outbreaks of debilitating tropical diseases becoming Europe’s ‘new normal’  The Telegraph
4. West Nile virus, chikungunya, dengue: Tracking mosquito-borne illnesses across Europe  MSN
5. Surge in Mosquito-Borne “Suitcase Viruses” Across Europe: What Travelers Need to Know  Vocal

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2 Harlem construction workers sue contractors they blame for Legionnaires' outbreak - Gothamist

1. 2 Harlem construction workers sue contractors they blame for Legionnaires' outbreak  Gothamist
2. Four dead in New York City outbreak of Legionnaires' disease  BBC
3. Lawsuits accuse construction companies in NYC in deadly Legionnaires outbreak  NBC News
4. Five deaths reported amid bacterial infection outbreak in major city  Fox News
5. New York City Death Toll From Legionnaires Outbreak Rises to Six  Bloomberg.com

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Lawsuits accuse construction companies in NYC in deadly Legionnaires outbreak - NBC News

1. Lawsuits accuse construction companies in NYC in deadly Legionnaires outbreak  NBC News
2. NYC legionnaires' outbreak: New lawsuit accuses construction companies of of negligence at Harlem Hospital  ABC7 New York
3. This deadly bacteria was once an “only in New York” problem. Not anymore.  vox.com
4. Five deaths reported amid bacterial infection outbreak in major city  Fox News
5. 5 dead, 108 sickened in New York City Legionnaires' disease outbreak  USA Today

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August 20, 2025 at 10:58PM CBER 2025 Orphan Approvals (new BLAs)

CBER 2025 Orphan Approvals (new BLAs)

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This deadly bacteria was once an “only in New York” problem. Not anymore. - vox.com

1. This deadly bacteria was once an “only in New York” problem. Not anymore.  vox.com
2. 5th person dies after a Legionnaires’ disease outbreak sickens dozens in New York City  ABC News
3. How does Legionnaires’ disease spread? What to know about NYC outbreak  USA Today
4. NYC legionnaires' outbreak: Fifth person dies amid cluster in Harlem as cases rise to 108  ABC7 New York
5. Lawsuit blames construction company for Legionnaires’ disease outbreak  FOX 5 New York

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Texas has declared its measles outbreak over. The threat still looms. - The Washington Post

1. Texas has declared its measles outbreak over. The threat still looms.  The Washington Post
2. Measles outbreak that sickened more than 700 declared over in Texas  ABC News
3. State health officials: The West Texas measles outbreak has ended  Texas Public Radio | TPR
4. As Texas Declares Measles Outbreak Over, Denver Airport Announces Exposure  People.com
5. The West Texas Measles Outbreak Has Ended  WIRED

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5th person dies after a Legionnaires’ disease outbreak sickens dozens in New York City - ABC News

1. 5th person dies after a Legionnaires’ disease outbreak sickens dozens in New York City  ABC News
2. NYC legionnaires' outbreak: Officials identify 10 buildings tied to Harlem outbreak, including hospital; 4th death announced  abc7ny.com
3. 5 dead, 108 sickened in New York City Legionnaires' disease outbreak  USA Today
4. NYC Legionnaires' disease outbreak: 5th person has died  FOX 5 New York
5. Harlem Hospital's cooling towers spread Legionnaires' disease in deadly NYC outbreak  New York Post

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5th person dies after a Legionnaires’ disease outbreak sickens dozens in New York City - ABC News

1. 5th person dies after a Legionnaires’ disease outbreak sickens dozens in New York City  ABC News
2. 5 dead, 108 sickened in New York City Legionnaires' disease outbreak  USA Today
3. NYC legionnaires' outbreak: Officials identify 10 buildings tied to Harlem outbreak, including hospital; 4th death announced  abc7ny.com
4. NYC Legionnaires' disease outbreak: 5th person has died  FOX 5 New York
5. Harlem Hospital's cooling towers spread Legionnaires' disease in deadly NYC outbreak  New York Post

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The Texas Measles Outbreak Is Over, Officials Say - The New York Times

1. The Texas Measles Outbreak Is Over, Officials Say  The New York Times
2. Measles outbreak is over, Texas health officials say  CNN
3. State officials declare West Texas measles outbreak over  CIDRAP
4. Measles outbreak that sickened more than 700 declared over in Texas  ABC News
5. Texas has declared its measles outbreak over. The threat still looms.  The Washington Post

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NYC Legionnaires' disease cluster grows to more than 100 cases, including 4 deaths - WGAL

1. NYC Legionnaires' disease cluster grows to more than 100 cases, including 4 deaths  WGAL
2. NYC legionnaires' outbreak: Fifth person dies amid cluster in Harlem as cases rise to 108  ABC7 New York
3. Four dead in New York City outbreak of Legionnaires' disease  BBC
4. 4th person dies after a Legionnaires’ disease outbreak sickens dozens in New York City  AP News
5. Fifth death in Central Harlem linked to Legionnaires' disease  Gothamist

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NYC Legionnaires' disease cluster grows to more than 100 cases, including 4 deaths - WGAL

1. NYC Legionnaires' disease cluster grows to more than 100 cases, including 4 deaths  WGAL
2. NYC legionnaires' outbreak: Fifth person dies amid cluster in Harlem as cases rise to 108  ABC7 New York
3. Four dead in New York City outbreak of Legionnaires' disease  BBC
4. NYC Legionnaires' disease outbreak: 5th person has died  FOX 5 New York
5. NYC Legionnaires’ disease cases rise to 90 as city health officials propose new cooling tower regulations  CNN

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Texas declares measles outbreak over - AP News

1. Texas declares measles outbreak over  AP News
2. Measles outbreak is over, Texas health officials say  CNN
3. Measles outbreak that sickened more than 700 declared over in Texas  ABC News
4. Measles outbreak is over in Texas, state health officials declare  CBS News
5. Measles outbreak at the center of record US case numbers officially over, Texas says  USA Today

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Texas declares measles outbreak over - AP News

Texas declares measles outbreak over  AP NewsView Full Coverage on Google News

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August 18, 2025 at 05:09PM Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions


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August 18, 2025 at 04:15PM Approaches to Assessment of Overall Survival in Oncology Clinical Trials

Approaches to Assessment of Overall Survival in Oncology Clinical Trials

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Legionnaires' disease cluster in New York City causes a 4th death, sickens over 100 people. What is it, and how do you get it? - yahoo.com

1. Legionnaires' disease cluster in New York City causes a 4th death, sickens over 100 people. What is it, and how do you get it?  yahoo.com
2. Four dead in New York City outbreak of Legionnaires' disease  BBC
3. NYC Legionnaires’ disease cluster grows to more than 100 cases, including 4 deaths  CNN
4. NYC legionnaires' outbreak: Final cooling tower in Harlem cluster remediated after 4th death  ABC7 New York
5. Harlem residents accuse NYC of shirking life-saving inspections amid deadly Legionnaires’ disease outbreak: ‘Irresponsible’  New York Post

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NYC Legionnaires’ disease cluster grows to 99 cases, 4 deaths - CNN

1. NYC Legionnaires’ disease cluster grows to 99 cases, 4 deaths  CNN
2. NYC legionnaires' outbreak: Officials identify 10 buildings tied to Harlem outbreak, including hospital; 4th death announced  ABC7 New York
3. Four dead in New York City outbreak of Legionnaires' disease  BBC
4. Legionnaire's: 12 cooling towers test positive for live bacteria, 99 cases confirmed  FOX 5 New York
5. Legionnaires’ outbreak in Harlem exposes grim future risks for NYC as steep Medicaid cuts loom | amNewYork  amNewYork

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NYC Legionnaires’ disease cluster grows to 99 cases, 4 deaths - CNN

1. NYC Legionnaires’ disease cluster grows to 99 cases, 4 deaths  CNN
2. Four dead in New York City outbreak of Legionnaires' disease  BBC
3. NYC legionnaires' outbreak: Officials identify 10 buildings tied to Harlem outbreak, including hospital; 4th death announced  ABC7 New York
4. Legionnaire's: 12 cooling towers test positive for live bacteria, 99 cases confirmed  FOX 5 New York
5. Legionnaires’ outbreak in Harlem exposes grim future risks for NYC as steep Medicaid cuts loom | amNewYork  amNewYork

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Four dead in New York City outbreak of Legionnaires' disease - BBC

1. Four dead in New York City outbreak of Legionnaires' disease  BBC
2. NYC Legionnaires’ disease cluster grows to 99 cases, 4 deaths  CNN
3. NYC legionnaires' outbreak: Officials identify 10 buildings tied to Harlem outbreak, including hospital; 4th death announced  ABC7 New York
4. Legionnaire's: 12 cooling towers test positive for live bacteria, 99 cases confirmed  FOX 5 New York
5. Legionnaires’ outbreak in Harlem exposes grim future risks for NYC as steep Medicaid cuts loom | amNewYork  amNewYork

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Four dead in New York City outbreak of Legionnaires' disease - BBC

1. Four dead in New York City outbreak of Legionnaires' disease  BBC
2. NYC Legionnaires’ disease cluster grows to 99 cases, 4 deaths  CNN
3. NYC legionnaires' outbreak: Officials identify 10 buildings tied to Harlem outbreak, including hospital; 4th death announced  ABC7 New York
4. Legionnaire's: 12 cooling towers test positive for live bacteria, 99 cases confirmed  FOX 5 New York
5. Legionnaires’ outbreak in Harlem exposes grim future risks for NYC as steep Medicaid cuts loom | amNewYork  amNewYork

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4th person dies after a Legionnaires’ disease outbreak sickens dozens in New York City - ABC News

4th person dies after a Legionnaires’ disease outbreak sickens dozens in New York City  ABC NewsView Full Coverage on Google News

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Sudan Hit by Its ‘Worst Cholera Outbreak’ in Years, Medical Charity Says - The New York Times

1. Sudan Hit by Its ‘Worst Cholera Outbreak’ in Years, Medical Charity Says  The New York Times
2. Sudan’s Famine Enters Dangerous New Phase  The Wall Street Journal
3. Cholera is spreading rapidly in Darfur in the worst outbreak in years  AP News
4. Sudan cholera outbreak kills 40 in a week as health centres overwhelmed  The Guardian
5. Sudan suffers deadly cholera outbreak  BBC

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