US measles total nears 1,100 cases as Colorado reports airline cluster - CIDRAP

1. US measles total nears 1,100 cases as Colorado reports airline cluster  CIDRAP
2. Measles Outbreak on Flight to Denver Sickens 3, Including Young Child  People.com
3. Officials sound alarm after three travelers from same international flight contract measles at Denver airport  New York Post
4. As Colorado measles cases grow, doctors share who does, and doesn't, need boosters  CBS News
5. 3rd measles case linked to international flight that landed at DIA  9News

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US measles total nears 1,100 cases as Colorado reports airline cluster - CIDRAP

1. US measles total nears 1,100 cases as Colorado reports airline cluster  CIDRAP
2. As Colorado measles cases grow, doctors share who does, and doesn't, need boosters  CBS News
3. Texas' measles outbreak is starting to slow. The U.S. case count climbs slightly to 1,024 cases  Los Angeles Times
4. Health officials advise some people should not get measles vaccine, despite the outbreak in Texas  KXXV
5. Measles cases seem to be slowing down in the US. What's behind it?  ABC News

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Measles Outbreak on Flight to Denver Sickens 3, Including Young Child - AOL.com

Measles Outbreak on Flight to Denver Sickens 3, Including Young Child  AOL.comView Full Coverage on Google News

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Measles Outbreak on Flight to Denver Sickens 3, Including Young Child - AOL.com

Measles Outbreak on Flight to Denver Sickens 3, Including Young Child  AOL.comView Full Coverage on Google News

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3rd measles case linked to international flight that landed at DIA - 9News

1. 3rd measles case linked to international flight that landed at DIA  9News
2. Another Colorado measles case tied to Turkish Airlines flight into DIA  The Denver Post
3. Measles case confirmed in vaccinated Coloradan who flew into DIA  KDVR
4. Measles Outbreak on Flight to Denver Sickens 3, Including Young Child  People.com
5. Unvaccinated Colorado child tests positive for measles after travel, visited Aurora stores while contagious  CBS News

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Measles Outbreak on Flight to Denver Sickens 3, Including Young Child - AOL.com

Measles Outbreak on Flight to Denver Sickens 3, Including Young Child  AOL.comView Full Coverage on Google News

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May 30, 2025 at 08:33PM Ongoing | Infectious Disease Accelerated Approvals Vaccines

Biologic Accelerated Approvals Based on a Surrogate Endpoint

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3rd measles case linked to international flight that landed at DIA - 9News

1. 3rd measles case linked to international flight that landed at DIA  9News
2. Measles case confirmed in vaccinated Coloradan who flew into DIA  KDVR
3. Another Colorado measles case tied to Turkish Airlines flight into DIA  The Denver Post
4. Colorado confirms second measles outbreak of 2025 as cases reach numbers not seen in nearly 30 years  Denver7
5. Officials sound alarm after three travelers from same international flight contract measles at Denver airport  New York Post

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May 30, 2025 at 03:43PM Devices Guidances

This page lists Medical Device Guidance documents.

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May 29, 2025 at 10:20PM CBER Rare Disease Program

Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.

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Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier - AP News

1. Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier  AP News
2. Texas Legislature approves making vaccine exemption process easier  The Texas Tribune
3. New Texas bill makes it easier to request vaccine exemptions  ABC News
4. Energized by Kennedy, Texas ‘Mad Moms’ Are Chipping Away at Vaccine Mandates  The New York Times
5. Vaccination exemption bill heads to governor’s desk, local pediatrician urges caution  kiiitv.com

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Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier - AP News

1. Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier  AP News
2. Amid measles outbreak, Texas lawmakers vote to make school vaccine exemptions easier  PBS
3. Texas Legislature approves making vaccine exemption process easier  The Texas Tribune
4. New Texas bill makes it easier to request vaccine exemptions  ABC News
5. Energized by Kennedy, Texas ‘Mad Moms’ Are Chipping Away at Vaccine Mandates  The New York Times

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Measles cases seem to be slowing down in the US. What's behind it? - ABC News

1. Measles cases seem to be slowing down in the US. What's behind it?  ABC News
2. How much worse could America’s measles outbreak get?  The Economist
3. Measles vaccines save millions of lives each year  Our World in Data
4. US measles case count climbs slightly to 1,046 cases, while Indiana's outbreak ends  NBC Montana
5. Indiana measles outbreak ends, Allen County says  Mirror Indy

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Measles cases seem to be slowing down in the US. What's behind it? - ABC News

1. Measles cases seem to be slowing down in the US. What's behind it?  ABC News
2. How much worse could America’s measles outbreak get?  The Economist
3. Measles vaccines save millions of lives each year  Our World in Data
4. US measles case count climbs slightly to 1,046 cases, while Indiana's outbreak ends  NBC Montana
5. Indiana measles outbreak ends, Allen County says  Mirror Indy

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Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier - AP News

Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier  AP NewsView Full Coverage on Google News

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Measles cases reach 1,046 in US as infections confirmed in 30 states: CDC - ABC News

1. Measles cases reach 1,046 in US as infections confirmed in 30 states: CDC  ABC News
2. How much worse could America’s measles outbreak get?  The Economist
3. Measles vaccines save millions of lives each year  Our World in Data
4. Medical experts recommend measles vaccine  FOX 2
5. US measles case count climbs slightly to 1,046 cases, while Indiana's outbreak ends, CDC says  ABC13 Houston

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Family likely infected with fungal disease after bat-filled cave tour: CDC - NewsNation

1. Family likely infected with fungal disease after bat-filled cave tour: CDC  NewsNation
2. Vacation nightmare: 12 family members diagnosed with fungal disease after exploring Costa Rica cave  Fox News
3. Cave-Associated Histoplasmosis Outbreak ...  Centers for Disease Control and Prevention | CDC (.gov)
4. Family likely infected with histoplasmosis in bat-colonized cave  CIDRAP
5. A family visited a bat cave in Costa Rica. They were then infected with a fungal disease.  USA Today

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Family likely infected with fungal disease after bat-filled cave tour: CDC - NewsNation

1. Family likely infected with fungal disease after bat-filled cave tour: CDC  NewsNation
2. Vacation nightmare: 12 family members diagnosed with fungal disease after exploring Costa Rica cave  Fox News
3. Cave-Associated Histoplasmosis Outbreak ...  Centers for Disease Control and Prevention | CDC (.gov)
4. Family likely infected with histoplasmosis in bat-colonized cave  CIDRAP
5. A family visited a bat cave in Costa Rica. They were then infected with a fungal disease.  USA Today

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Family likely infected with fungal disease after bat-filled cave tour: CDC - NewsNation

1. Family likely infected with fungal disease after bat-filled cave tour: CDC  NewsNation
2. Vacation nightmare: 12 family members diagnosed with fungal disease after exploring Costa Rica cave  Fox News
3. Cave-Associated Histoplasmosis Outbreak ...  Centers for Disease Control and Prevention | CDC (.gov)
4. Family likely infected with histoplasmosis in bat-colonized cave  CIDRAP
5. A family visited a bat cave in Costa Rica. They were then infected with a fungal disease.  USA Today

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As measles outbreak continues, new parents in Lubbock face unexpected fears - The Texas Tribune

1. As measles outbreak continues, new parents in Lubbock face unexpected fears  The Texas Tribune
2. First measles case of the year confirmed in Williamson County at Liberty Hill ISD  KXAN Austin
3. Measles Outbreak Updates: Here's Where Cases Are Spreading In The U.S.  Forbes
4. Second unvaccinated child in same household contracts measles: Waco-McLennan County health district  KWTX
5. Williamson County confirms first measles case of 2025 in school-aged child  KUT

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May 22, 2025 at 11:16PM COVID-19 Vaccines (2025-2026 Formula) for Use in the United States Beginning in Fall 2025

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on May 22, 2025, to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States beginning in the fall of 2025.

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May 22, 2025 at 11:08PM Flublok Quadrivalent

Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older.

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As measles outbreak continues, new parents in Lubbock face unexpected fears - The Texas Tribune

1. As measles outbreak continues, new parents in Lubbock face unexpected fears  The Texas Tribune
2. Measles Outbreak Updates: Here's Where Cases Are Spreading In The U.S.  Forbes
3. Second unvaccinated child in same household contracts measles: Waco-McLennan County health district  KWTX
4. Texas and Georgia announce more measles cases  CIDRAP
5. Texas Measles Outbreak Slows After Major Vaccine Push  Bloomberg

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Measles Alert In New Jersey After Infected Person Attends Sold-Out Shakira Show - HuffPost

1. Measles Alert In New Jersey After Infected Person Attends Sold-Out Shakira Show  HuffPost
2. Officials warn of potential measles exposure at Shakira concert at MetLife Stadium  NBC10 Philadelphia
3. Shakira concert measles: Health Department alerts possible exposure at Thursday night show at MetLife Stadium  ABC7 New York
4. Measles warning issued following Shakira concert at MetLife  New York Daily News
5. Shakira Concertgoers Issued Urgent Warning After Measles Outbreak  The Daily Beast

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Family vacation takes hellish turn as relatives come down with cancer-like disease - Daily Mail

1. Family vacation takes hellish turn as relatives come down with cancer-like disease  Daily Mail
2. A family visited a bat cave in Costa Rica. They were then infected with a fungal disease.  USA Today
3. Cave-Associated Histoplasmosis Outbreak ...  Centers for Disease Control and Prevention | CDC (.gov)
4. Family likely infected with histoplasmosis in bat-colonized cave  CIDRAP
5. U.S. Family Infected With Airborne Fungal Disease After Touring Bat-Filled Caves  Gizmodo

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May 22, 2025 at 01:19PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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Officials warn of potential measles exposure at Shakira concert at MetLife Stadium - NBC News

1. Officials warn of potential measles exposure at Shakira concert at MetLife Stadium  NBC News
2. Person with measles attended Shakira concert, N.J. health officials say  CBS News
3. Shakira Concertgoers Issued Urgent Warning After Measles Outbreak  The Daily Beast
4. Person may have spread measles at Shakira concert in MetLife Stadium, health officials say  Bergen Record
5. Measles warning issued following Shakira concert at MetLife  New York Daily News

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Major outbreak fears as world's most infectious disease hits Shakira concert at Metlife stadium - Daily Mail

1. Major outbreak fears as world's most infectious disease hits Shakira concert at Metlife stadium  Daily Mail
2. Measles exposure alert issued for Shakira concert at MetLife Stadium, NJ health officials say  Gothamist
3. Person may have spread measles at Shakira's New Jersey concert, health officials warn  USA Today
4. Shakira concert measles: Health Department alerts possible exposure at Thursday night show at MetLife Stadium  ABC7 New York
5. Shakira concertgoers may have been exposed to measles at sold-out MetLife show, NJ health officials warn  New York Post

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May 20, 2025 at 03:20PM Supreme Rejuvenation, LLC - 700749 - 05/05/2025

Unapproved New Drugs/Misbranded

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Tornado watch extended for Kansas City as storms, hail batter area - Kansas City Star

1. Tornado watch extended for Kansas City as storms, hail batter area  Kansas City Star
2. Millions prepare for severe storms in the Midwest and South  NPR
3. Severe Weather Outbreak Packs Tornado Threat In Midwest And South  The Weather Channel
4. Tornado damage reported in Arkansas, Oklahoma as severe weather rips through central US  FOX Weather
5. Strong tornadoes threaten millions more in the central US after a weekend of violent storms that left at least 28 dead  CNN

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The US hasn't seen a human bird flu case in 3 months. Experts are wondering why - Medical Xpress

1. The US hasn't seen a human bird flu case in 3 months. Experts are wondering why  Medical Xpress
2. Bird flu in humans hasn't officially been seen in U.S. in 3 months: "We just don't know why"  CBS News
3. The worst of avian flu outbreak may be over in California, health officials say  San Francisco Chronicle
4. The US hasn’t seen a human bird flu case in 3 months. Experts are wondering why  Colorado Hometown Weekly
5. The US hasn't seen a human bird flu case in three months. Experts are wondering why  Stuff

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Interactive map shows all damage, entire track of St. Louis' deadly tornado - KSDK

1. Interactive map shows all damage, entire track of St. Louis' deadly tornado  KSDK
2. Tornadoes, storms wreak havoc across Midwest: See aerial footage from Kentucky, Missouri  USA Today
3. 'A pain I can't describe': Tornadoes sweep multiple US states  BBC
4. 30 million people brace for more severe weather after deadly tornado outbreak  ABC News
5. How to help victims of deadly Kentucky tornado  WLKY

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A rare tornado ripped through St. Louis. Days later, a community picks up the pieces - CNN

1. A rare tornado ripped through St. Louis. Days later, a community picks up the pieces  CNN
2. Recovery efforts underway in Kentucky, Missouri as tornado outbreak death toll continues to rise  FOX Weather
3. $1 billion in damage; financial donations 'badly needed,' mayor says  KSDK
4. 'We're gonna need a lot of help': Gov. Beshear responds to deadly tornadoes  LEX18
5. Morganfield residents react to Friday night storm damage  14news.com

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Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC - ABC News

1. Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC  ABC News
2. US measles cases surpass 1K: CDC  The Hill
3. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
4. Measles outbreak raises concern for Texans with immune issues  Dallas News
5. US measles outbreak grows to 1,024 cases  CIDRAP

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Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC - ABC News

1. Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC  ABC News
2. US measles cases surpass 1K: CDC  The Hill
3. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
4. Measles outbreak raises concern for Texans with immune issues  Dallas News
5. US measles outbreak grows to 1,024 cases  CIDRAP

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US measles cases surpass 1K: CDC - The Hill

1. US measles cases surpass 1K: CDC  The Hill
2. Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC  ABC News
3. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
4. Measles outbreak raises concern for Texans with immune issues  Dallas News
5. US measles outbreak grows to 1,024 cases  CIDRAP

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US measles cases surpass 1K: CDC - The Hill

1. US measles cases surpass 1K: CDC  The Hill
2. Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC  ABC News
3. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
4. Measles outbreak raises concern for Texans with immune issues  Dallas News
5. US measles outbreak grows to 1,024 cases  CIDRAP

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At least 9 confirmed dead in 'mass casualty' event in Laurel County - LEX18

1. At least 9 confirmed dead in 'mass casualty' event in Laurel County  LEX18
2. Kentucky tornadoes leave multiple dead as severe weather outbreak tears across Ohio Valley  FOX Weather
3. Severe storms rip through Midwest, killing at least 16, including 9 in Kentucky tornado: ‘This is truly, truly devastating’  New York Post
4. Numerous homes and businesses damaged or destroyed by tornado in Pulaski County  WKYT
5. Nine people dead in Kentucky after tornado hits Laurel County; search continues for survivors  WLKY

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US measles cases surpass 1K: CDC - The Hill

1. US measles cases surpass 1K: CDC  The Hill
2. US measles outbreak grows to 1,024 cases  CIDRAP
3. Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC  ABC News
4. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
5. How much worse could America’s measles outbreak get?  The Economist

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Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC - ABC News

1. Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC  ABC News
2. US measles cases surpass 1K: CDC  The Hill
3. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
4. Measles outbreak raises concern for Texans with immune issues  Dallas News
5. How much worse could America’s measles outbreak get?  The Economist

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Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC - ABC News

1. Measles cases reach 1,024 in the US as infections confirmed in 30 states: CDC  ABC News
2. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
3. How much worse could America’s measles outbreak get?  The Economist
4. Measles outbreak raises concern for Texans with immune issues  Dallas News
5. US Measles Cases Grow 2.3% in a Week as Outbreak Appears to Slow  Bloomberg.com

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Millions under threat of strong tornadoes and violent winds as storm danger increases Friday - CNN

1. Millions under threat of strong tornadoes and violent winds as storm danger increases Friday  CNN
2. Renewed severe weather outbreak threatens over 140 million with giant hail, strong tornadoes and extreme gusts  FOX Weather
3. TIMELINE | Hour-by-hour breakdown of Friday's strong storms  WLKY
4. Multiday Outbreak Of Severe Weather, Tornado Threat Will Shift From Midwest To Plains Through Early Next Week  The Weather Channel
5. Multiple tornadoes reported in Minnesota, Wisconsin  FOX 9 Minneapolis-St. Paul

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How much worse could America’s measles outbreak get? - The Economist

1. How much worse could America’s measles outbreak get?  The Economist
2. The US has 1,001 measles cases and 11 states with active outbreaks  AP News
3. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
4. Texas announces more measles cases, including first in Dallas area  CIDRAP
5. World's most infectious disease hits major US city of 8 million prompting major outbreak fears  Daily Mail

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How much worse could America’s measles outbreak get? - The Economist

1. How much worse could America’s measles outbreak get?  The Economist
2. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
3. Texas announces more measles cases, including first in Dallas area  CIDRAP
4. World's most infectious disease hits major US city of 8 million prompting major outbreak fears  Daily Mail
5. The rapid spread of measles in Gaines, Texas  Reuters

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How much worse could America’s measles outbreak get? - The Economist

1. How much worse could America’s measles outbreak get?  The Economist
2. Texas announces more measles cases, including first in Dallas area  CIDRAP
3. World's most infectious disease hits major US city of 8 million prompting major outbreak fears  Daily Mail
4. Measles math: What to know about 1,001 measles cases across the country : Shots - Health News  NPR
5. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News

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How much worse could America’s measles outbreak get? - The Economist

1. How much worse could America’s measles outbreak get?  The Economist
2. Texas announces more measles cases, including first in Dallas area  CIDRAP
3. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
4. Measles math: What to know about 1,001 measles cases across the country : Shots - Health News  NPR
5. The rapid spread of measles in Gaines, Texas  Reuters

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How much worse could America’s measles outbreak get? - The Economist

1. How much worse could America’s measles outbreak get?  The Economist
2. ‘We tried to save those kids’: Texas doctor watched children die of measles. Now it’s back in Texas  KERA News
3. Texas announces more measles cases, including first in Dallas area  CIDRAP
4. The US has 1,001 measles cases and 11 states with active outbreaks  AP News
5. The rapid spread of measles in Gaines, Texas  Reuters

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May 14, 2025 at 12:05PM JYNNEOS

Indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.


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More than 800 Fargo-Moorhead area students are not vaccinated for measles, districts say - InForum

1. More than 800 Fargo-Moorhead area students are not vaccinated for measles, districts say  InForum
2. Measles cases rise to 11 in North Dakota after two new infections reported in Cass County  MPR News
3. Experts encourage Measles vaccine following Cass County cases  Valley News Live
4. About 180 students under quarantine amid measles outbreak in North Dakota  KTVQ
5. Montana health officials keep close eye on North Dakota measles outbreak  YPR

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More than 800 Fargo-Moorhead area students are not vaccinated for measles, districts say - InForum

1. More than 800 Fargo-Moorhead area students are not vaccinated for measles, districts say  InForum
2. Measles cases rise to 11 in North Dakota after two new infections reported in Cass County  MPR News
3. Experts encourage Measles vaccine following Cass County cases  Valley News Live
4. About 180 students under quarantine amid measles outbreak in North Dakota  KTVQ
5. Montana health officials keep close eye on North Dakota measles outbreak  YPR

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