Tuesday, September 30, 2025

September 30, 2025 at 05:47PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes

Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Blood and Plasma Establishments," (https://ift.tt/tl9MkuP) to determ

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Saturday, September 27, 2025

Ebola outbreak in DR Congo rages, with 61% death rate and funding running dry - Ars Technica

  1. Ebola outbreak in DR Congo rages, with 61% death rate and funding running dry  Ars Technica
  2. Health authorities sound the alarm as 35 deaths linked to new Ebola outbreak  The Independent
  3. What a new Ebola outbreak in DR Congo means for people in the US  CNN
  4. Ebola Outbreak in the Democratic Republic of the Congo | HAN  Centers for Disease Control and Prevention | CDC (.gov)
  5. DR Congo: UNICEF delivers vaccines and life-saving support as Ebola outbreak hits Kasai  UNICEF


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Ebola outbreak in DR Congo rages, with 61% death rate and funding running dry - Ars Technica

  1. Ebola outbreak in DR Congo rages, with 61% death rate and funding running dry  Ars Technica
  2. Health authorities sound the alarm as 35 deaths linked to new Ebola outbreak  The Independent
  3. What a new Ebola outbreak in DR Congo means for people in the US  CNN
  4. Ebola Outbreak in the Democratic Republic of the Congo | HAN  Centers for Disease Control and Prevention | CDC (.gov)
  5. DR Congo: UNICEF delivers vaccines and life-saving support as Ebola outbreak hits Kasai  UNICEF


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Ebola outbreak in DR Congo rages, with 61% death rate and funding running dry - Ars Technica

  1. Ebola outbreak in DR Congo rages, with 61% death rate and funding running dry  Ars Technica
  2. Health authorities sound the alarm as 35 deaths linked to new Ebola outbreak  The Independent
  3. Ebola Outbreak in the Democratic Republic of the Congo | HAN  Centers for Disease Control and Prevention | CDC (.gov)
  4. WHO confirms 11 new Ebola cases in Congo  Reuters
  5. What a new Ebola outbreak in DR Congo means for people in the US  CNN


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Friday, September 26, 2025

Listeria found in Walmart meatball meals may be linked to deadly fettuccine outbreak - KSL.com

Listeria found in Walmart meatball meals may be linked to deadly fettuccine outbreak  KSL.comView Full Coverage on Google News

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September 26, 2025 at 07:41PM MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug products marketed without an approved application.

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September 26, 2025 at 04:00PM MedWatch Forms for FDA Safety Reporting

Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online.

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Thursday, September 25, 2025

September 25, 2025 at 11:12PM ABECMA

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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September 25, 2025 at 07:31PM MNEXSPIKE

MNEXSPIKE is a vaccine indicated 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 are:
65 years of age and older, or
12 years through 64 years of age with

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September 25, 2025 at 04:17PM eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

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Wednesday, September 24, 2025

September 24, 2025 at 01:51PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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Monday, September 22, 2025

September 23, 2025 at 01:10AM Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

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September 23, 2025 at 01:08AM FDA use of Real-World Evidence in Regulatory Decision Making

The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) applied RWE in regulatory decision-making processes since 2011.

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Rare flesh eating-bacteria claims another victim as officials urge public to take precautions - Daily Mail

  1. Rare flesh eating-bacteria claims another victim as officials urge public to take precautions  Daily Mail
  2. 5 Dead, Dozens Hospitalized amid Outbreak of Flesh-Eating Bacteria Linked to Beaches and Seafood  People.com
  3. Louisiana reports five deaths from flesh-eating bacterium in coastal waters  The Guardian
  4. Number of cases of flesh-eating bacterial infections in Central Florida jumps to 28  WFTV
  5. Louisiana patient dies from flesh-eating bacteria as US sees dozens of cases this year  The Independent


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September 22, 2025 at 04:05PM 2025 Biological License Application Approvals

Listing of the 2025 Biological License Application Approvals

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September 22, 2025 at 02:40PM Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment Public Meeting - 09/24/2025

The Food and Drug Administration (FDA) is holding a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment on 9/24/2025.

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Rare flesh eating-bacteria claims another victim as officials urge public to take precautions - Daily Mail

  1. Rare flesh eating-bacteria claims another victim as officials urge public to take precautions  Daily Mail
  2. Louisiana reports five deaths from flesh-eating bacterium in coastal waters  The Guardian
  3. 5 Dead, Dozens Hospitalized amid Outbreak of Flesh-Eating Bacteria Linked to Beaches and Seafood  People.com
  4. Number of cases of flesh-eating bacterial infections in Central Florida jumps to 28  WFTV
  5. Are raw oysters safe to eat? A seafood expert has answers  Magnolia Reporter


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Saturday, September 20, 2025

Rare flesh eating-bacteria claims another victim as officials urges public to take precautions - Daily Mail

  1. Rare flesh eating-bacteria claims another victim as officials urges public to take precautions  Daily Mail
  2. Louisiana reports five deaths from flesh-eating bacterium in coastal waters  The Guardian
  3. 5 Dead, Dozens Hospitalized amid Outbreak of Flesh-Eating Bacteria Linked to Beaches and Seafood  People.com
  4. Number of cases of flesh-eating bacterial infections in Central Florida jumps to 28  WFTV
  5. Louisiana patient dies from flesh-eating bacteria as US sees dozens of cases this year  The Independent


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Deaths in Ebola outbreak surge 63% as towns remain on lockdown to prevent pandemic - Daily Mail

  1. Deaths in Ebola outbreak surge 63% as towns remain on lockdown to prevent pandemic  Daily Mail
  2. Ebola Outbreak in the Democratic Republic of the Congo | HAN  Centers for Disease Control and Prevention | CDC (.gov)
  3. 31 of 38 Ebola cases in Congo have resulted in deaths, WHO reports  PBS
  4. Ebola vaccination begins in the Democratic Republic of the Congo  WHO | Regional Office for Africa
  5. WHO: 31 of 48 Ebola cases in DRC have died in latest outbreak  upi.com


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Friday, September 19, 2025

Louisiana reports five deaths from flesh-eating bacterium in coastal waters - The Guardian

  1. Louisiana reports five deaths from flesh-eating bacterium in coastal waters  The Guardian
  2. 5 Dead, Dozens Hospitalized amid Outbreak of Flesh-Eating Bacteria Linked to Beaches and Seafood  People.com
  3. Number of cases of flesh-eating bacterial infections in Central Florida jumps to 28  WFTV
  4. Flesh-eating bacteria are becoming more pervasive—here’s why  National Geographic
  5. Vibrio vulnificus permeates the waters of coastal Mass.  The Tufts Daily


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Louisiana reports five deaths from flesh-eating bacterium in coastal waters - The Guardian

  1. Louisiana reports five deaths from flesh-eating bacterium in coastal waters  The Guardian
  2. 5 Dead, Dozens Hospitalized amid Outbreak of Flesh-Eating Bacteria Linked to Beaches and Seafood  People.com
  3. Number of cases of flesh-eating bacterial infections in Central Florida jumps to 28  WFTV
  4. Flesh-eating bacteria are becoming more pervasive—here’s why  National Geographic
  5. Vibrio vulnificus permeates the waters of coastal Mass.  The Tufts Daily


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Louisiana reports five deaths from flesh-eating bacterium in coastal waters - The Guardian

  1. Louisiana reports five deaths from flesh-eating bacterium in coastal waters  The Guardian
  2. Flesh-eating bacteria kills 5th person this year in Louisiana  CBS News
  3. 5 Dead, Dozens Hospitalized amid Outbreak of Flesh-Eating Bacteria Linked to Beaches and Seafood  People.com
  4. Fifth Louisiana death confirmed as Vibrio surge continues across Gulf Coast  WAFB
  5. Number of cases of flesh-eating bacterial infections in Central Florida jumps to 28  WFTV


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Deaths in Ebola outbreak surge 63% as towns remain on lockdown to prevent pandemic - Daily Mail

  1. Deaths in Ebola outbreak surge 63% as towns remain on lockdown to prevent pandemic  Daily Mail
  2. Ebola Outbreak in the Democratic Republic of the Congo | HAN  Centers for Disease Control and Prevention | CDC (.gov)
  3. WHO: 31 of 48 Ebola cases in DRC have died in latest outbreak  upi.com
  4. DR Congo Ebola cases rise as outbreak response gains traction  CIDRAP
  5. Ebola returns to Congo  The Economist


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Deaths in Ebola outbreak surge 63% as towns remain on lockdown to prevent pandemic - Daily Mail

  1. Deaths in Ebola outbreak surge 63% as towns remain on lockdown to prevent pandemic  Daily Mail
  2. Ebola Outbreak in the Democratic Republic of the Congo | HAN  Centers for Disease Control and Prevention | CDC (.gov)
  3. Over 30 people have died from Ebola in Congo, says World Health Organization  Reuters
  4. WHO: 31 of 48 Ebola cases in DRC have died in latest outbreak  upi.com
  5. 31 of 38 Ebola cases in Congo have resulted in deaths, WHO reports  PBS


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September 19, 2025 at 01:50PM 2025 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the 2025 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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Thursday, September 18, 2025

WHO says Ebola outbreak in DR Congo kills 31 - Al Jazeera

  1. WHO says Ebola outbreak in DR Congo kills 31  Al Jazeera
  2. Over 30 people have died from Ebola in Congo, says World Health Organization  Reuters
  3. Democratic Republic of the Congo (DRC), Emergency Appeal MDRCD047 - Ebola  ReliefWeb
  4. 31 of 38 Ebola cases in Congo have resulted in deaths, WHO reports  PBS
  5. A new Ebola outbreak has been declared. Here’s what we know  The Independent


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WHO says Ebola outbreak in DR Congo kills 31 - Al Jazeera

  1. WHO says Ebola outbreak in DR Congo kills 31  Al Jazeera
  2. Over 30 people have died from Ebola in Congo, says World Health Organization  Reuters
  3. Democratic Republic of the Congo (DRC), Emergency Appeal MDRCD047 - Ebola  ReliefWeb
  4. 31 of 38 Ebola cases in Congo have resulted in deaths, WHO reports  PBS
  5. A new Ebola outbreak has been declared. Here’s what we know  The Independent


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September 18, 2025 at 08:06PM Commissioner's National Priority Voucher (CNPV) Pilot Program

FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.

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Monday, September 15, 2025

There’s a new outbreak of Ebola in Africa. Here’s what you need to know - The Conversation

  1. There’s a new outbreak of Ebola in Africa. Here’s what you need to know  The Conversation
  2. A new Ebola outbreak has been declared. Here’s what we know  The Independent
  3. Ebola vaccination begins in southern Congo amid latest outbreak  PBS
  4. Ebola outbreak in the Democratic Republic of Congo is a warning  statnews.com
  5. Ebola vaccination begins in the Democratic Republic of the Congo  WHO | Regional Office for Africa


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There’s a new outbreak of Ebola in Africa. Here’s what you need to know - The Conversation

  1. There’s a new outbreak of Ebola in Africa. Here’s what you need to know  The Conversation
  2. Ebola vaccination begins in southern Congo  NBC News
  3. Ebola outbreak in the Democratic Republic of Congo is a warning  statnews.com
  4. Ebola cases in Congo rise as authorities race to contain spread of outbreak, health agency says  AP News
  5. Ebola vaccination begins in the Democratic Republic of the Congo  WHO | Regional Office for Africa


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Ebola vaccination begins in southern Congo amid latest outbreak - PBS

  1. Ebola vaccination begins in southern Congo amid latest outbreak  PBS
  2. Ebola outbreak in the Democratic Republic of Congo is a warning  statnews.com
  3. There’s a new outbreak of Ebola in Africa. Here’s what you need to know  The Conversation
  4. Ebola cases in Congo rise as authorities race to contain spread of outbreak, health agency says  AP News
  5. Ebola returns to Congo  The Economist


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Sunday, September 14, 2025

Ebola vaccination begins in southern Congo amid latest outbreak - PBS

  1. Ebola vaccination begins in southern Congo amid latest outbreak  PBS
  2. Ebola outbreak in the Democratic Republic of Congo is a warning  statnews.com
  3. Ebola cases in Congo rise as authorities race to contain spread of outbreak, health agency says  AP News
  4. Ebola returns to Congo  The Economist
  5. Ebola vaccination begins in the Democratic Republic of the Congo  WHO | Regional Office for Africa


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Ebola vaccination begins in southern Congo amid latest outbreak - PBS

  1. Ebola vaccination begins in southern Congo amid latest outbreak  PBS
  2. Ebola outbreak in the Democratic Republic of Congo is a warning  statnews.com
  3. Suspected cases in DR Congo Ebola outbreak rise to 68  CIDRAP
  4. Ebola returns to Congo  The Economist
  5. Ebola vaccination begins in the Democratic Republic of the Congo  WHO | Regional Office for Africa


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Ebola vaccination begins in southern Congo - NBC News

  1. Ebola vaccination begins in southern Congo  NBC News
  2. Ebola vaccination begins in southern Congo amid latest outbreak  PBS
  3. Ebola outbreak in the Democratic Republic of Congo is a warning  statnews.com
  4. Suspected cases in DR Congo Ebola outbreak rise to 68  CIDRAP
  5. Ebola returns to Congo  The Economist


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Thursday, September 11, 2025

September 11, 2025 at 10:15PM Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics

Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics

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September 11, 2025 at 09:14PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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September 11, 2025 at 02:31PM Workshops, Meetings & Conferences (Biologics)

Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

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Wednesday, September 10, 2025

September 10, 2025 at 08:47PM XYNTHA

XYNTHA is a recombinant antihemophilic factor indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.


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September 10, 2025 at 07:20PM Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

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September 10, 2025 at 05:56PM Biologics PREA Reviews and Labeling Changes

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under

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September 10, 2025 at 03:29PM 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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Tuesday, September 9, 2025

As Ebola outbreak kills 16 people in Congo, WHO official says Trump's aid cuts "will definitely have an impact" - CBS News

  1. As Ebola outbreak kills 16 people in Congo, WHO official says Trump's aid cuts "will definitely have an impact"  CBS News
  2. Democratic Republic of the Congo declares Ebola virus disease outbreak in Kasai Province  WHO | Regional Office for Africa
  3. New Ebola outbreak in DR Congo suspected of causing 15 deaths  CNN
  4. WHO shares more DR Congo Ebola outbreak details as more suspected cases reported  CIDRAP
  5. Ebola outbreak kills 15 in DR Congo  BBC


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As Ebola outbreak kills 16 people in Congo, WHO official says Trump's aid cuts "will definitely have an impact" - CBS News

  1. As Ebola outbreak kills 16 people in Congo, WHO official says Trump's aid cuts "will definitely have an impact"  CBS News
  2. Democratic Republic of the Congo declares Ebola virus disease outbreak in Kasai Province  WHO | Regional Office for Africa
  3. WHO shares more DR Congo Ebola outbreak details as more suspected cases reported  CIDRAP
  4. New Ebola outbreak in DR Congo suspected of causing 15 deaths  CNN
  5. Ebola outbreak kills 15 in DR Congo  BBC


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Saturday, September 6, 2025

Congo has announced a new Ebola outbreak. Here’s what to know - AP News

  1. Congo has announced a new Ebola outbreak. Here’s what to know  AP News
  2. 15 dead after new Ebola outbreak in the Democratic Republic of Congo  The Washington Post
  3. New Ebola outbreak in DR Congo suspected of causing 15 deaths  CNN
  4. The 16th Ebola Virus Disease Outbreak in Bulape Health Zone, Kasai, Democratic Republic of the Congo: A new spillover event from an unknown reservoir host  Virological
  5. Democratic Republic of the Congo declares Ebola virus disease outbreak in Kasai Province  WHO | Regional Office for Africa


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Congo has announced a new Ebola outbreak. Here’s what to know - AP News

  1. Congo has announced a new Ebola outbreak. Here’s what to know  AP News
  2. 15 dead after new Ebola outbreak in the Democratic Republic of Congo  The Washington Post
  3. The 16th Ebola Virus Disease Outbreak in Bulape Health Zone, Kasai, Democratic Republic of the Congo: A new spillover event from an unknown reservoir host  Virological
  4. New Ebola outbreak in DR Congo suspected of causing 15 deaths  CNN
  5. New Ebola Outbreak Confirmed in the Democratic Republic of Congo  Africa CDC


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15 dead after new Ebola outbreak in the Democratic Republic of Congo - The Washington Post

  1. 15 dead after new Ebola outbreak in the Democratic Republic of Congo  The Washington Post
  2. The 16th Ebola Virus Disease Outbreak in Bulape Health Zone, Kasai, Democratic Republic of the Congo: A new spillover event from an unknown reservoir host  Virological
  3. New Ebola outbreak in DR Congo suspected of causing 15 deaths  CNN
  4. New Ebola Outbreak Confirmed in the Democratic Republic of Congo  Africa CDC
  5. Congo has announced a new Ebola outbreak. Here's what to know  Star Tribune


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Mpox no longer an emergency but concerns remain, health body says - Reuters

  1. Mpox no longer an emergency but concerns remain, health body says  Reuters
  2. WHO chief says mpox outbreak in Africa is no longer a global health emergency  PBS
  3. Mpox no longer international health emergency but remains concern in Africa  Al Jazeera
  4. WHO Director-General's opening remarks at the media briefing – 5 September 2025  World Health Organization (WHO)
  5. Whatever happened to mpox? Is it still a threat?  NPR


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Friday, September 5, 2025

Salmonella outbreak linked to Metabolic Meals sickens more than a dozen people, 7 hospitalized, CDC says - CBS News

  1. Salmonella outbreak linked to Metabolic Meals sickens more than a dozen people, 7 hospitalized, CDC says  CBS News
  2. CDC puts out alert after more than a dozen get Salmonella likely from home delivery meals  WSB-TV
  3. When People Got Sick: Salmonella Outbreak, September 2025  Centers for Disease Control and Prevention | CDC (.gov)
  4. Salmonella outbreak linked to Metabolic Meals; CDC issues food safety alert  Food Safety News
  5. Home Delivered Metabolic Meals linked to 10 State Salmonella Outbreak  Marler Blog


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15 dead after new Ebola outbreak in the Democratic Republic of Congo - The Washington Post

  1. 15 dead after new Ebola outbreak in the Democratic Republic of Congo  The Washington Post
  2. New Ebola outbreak in DR Congo suspected of causing 15 deaths  CNN
  3. Democratic Republic of the Congo declares Ebola virus disease outbreak in Kasai Province  WHO | Regional Office for Africa
  4. New Ebola Outbreak Confirmed in the Democratic Republic of Congo  Africa CDC
  5. DR Congo announces new Ebola outbreak  Al Jazeera


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15 dead after new Ebola outbreak in the Democratic Republic of Congo - The Washington Post

  1. 15 dead after new Ebola outbreak in the Democratic Republic of Congo  The Washington Post
  2. New Ebola outbreak in DR Congo suspected of causing 15 deaths  CNN
  3. Democratic Republic of the Congo declares Ebola virus disease outbreak in Kasai Province  WHO | Regional Office for Africa
  4. New Ebola Outbreak Confirmed in the Democratic Republic of Congo  Africa CDC
  5. DR Congo announces new Ebola outbreak  Al Jazeera


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Thursday, September 4, 2025