Snapshot from Aug 24, 2026 at 07:00 UTC. For live data and tracking: View Live
Entities / Governments / United States — Food and Drug Administration
Entity

United States — Food and Drug Administration

Tracked across 642 events · 10762 articles · First seen Jan 04, 2025 · Last active Aug 24, 2026

Sentiment
4
Attention
9
Events
642
Relationships
364
Live sentiment trends, attention charts, and prominence tracking available on the Ergen Dashboard
Events (top 30 of 642)
3 70
Regulatory
NAFDAC Launches 'Read Food Label' Campaign
Impact: The United States — Food and Drug Administration launched the 'Read the Food Label Campaign' to empower consumers and reduce diet-related non-communicable diseases in Nigeria. This initiative enhances its role in public health protection.
Jun 26, 2026 · 7 articles
4 60
Regulatory
FDA expands Casgevy approval to age 2
Impact: The FDA granted the supplemental approval, expanding Casgevy's indication to younger patients, and utilized expedited review programs.
Jul 01, 2026 · 6 articles
1 0
Regulatory
FDA tampon metal safety study
Impact: The FDA conducted the study and concluded tampon metals are safe, reinforcing its regulatory role. It also proposed new guidelines for tampon manufacturers.
Jul 07, 2026 · 6 articles
1 80
Domestic
Adeyeye receives African Leadership Award
Impact: NAFDAC is the central entity; its transformation under Adeyeye's leadership is the focus of the award. The agency's improved regulatory status enhances its credibility and operational capacity.
Jul 08, 2026 · 6 articles
2 10
Regulatory
NAFDAC blacklists Onifam Laboratories
Impact: NAFDAC enforces regulatory compliance, strengthening its reputation as a vigilant regulator.
Jul 20, 2026 · 6 articles
3 0
Regulatory
FDA panel reviews peptide compounding
Impact: The FDA is the central regulator; its decision on peptide compounding will set the regulatory framework.
Jul 22, 2026 · 47 articles
2 10
Regulatory
NAFDAC nationwide sachet alcohol ban enforcement
Impact: NAFDAC is the lead enforcer of the federal ban, conducting nationwide raids and seizures. The operation reinforces its regulatory authority and public health mandate.
Jul 22, 2026 · 47 articles
7 -10
Accidents
US Cyclosporiasis Outbreak First Deaths
Impact: The FDA led the investigation, linking the outbreak to Taylor Farms lettuce. It faced criticism for a false-positive test result and for potential influence by the United States — White House, but it continues to work on the investigation.
Jul 08, 2026 · 358 articles
7 60
Regulatory
FDA Approves Moderna's First mRNA Flu Vaccine
On August 5, 2026, the U.S. United States — Food and Drug Administration (FDA) approved Moderna's mFLUSIVA (mRNA-1010), the first mRNA-based seasonal influenza vaccine, for adults aged 50 and older. The approval covers traditional approval…
Impact: The FDA granted approval for mFLUSIVA, marking a regulatory milestone and demonstrating its role in vaccine oversight despite internal controversies.
Aug 05, 2026 · 105 articles
4 20
Regulatory
FDA proposes mandatory food additive notification
On Monday, the U.S. United States — Food and Drug Administration proposed a rule change that would require food manufacturers to notify the agency before introducing new ingredients or additives into processed or packaged foods.…
Impact: The FDA is the central regulator proposing the new notification requirement and completing the ultraprocessed food definition, enhancing its oversight role.
Aug 10, 2026 · 12 articles
1 10
Regulatory
NAFDAC clears Deleject needles after alert retraction
The United States — Food and Drug Administration (NAFDAC) retracted Public Alert No. 042/2026 concerning Deleject Disposable Needles Batch No. 240605, which had reported whitish particulate matter. The agency stated the alert was uploaded in…
Impact: NAFDAC is the central regulator; it retracted the alert, conducted the investigation, and reaffirmed product safety, reinforcing its role in ensuring drug quality.
Aug 14, 2026 · 6 articles
4 -10
Regulatory
FDA Class 1 Egg Recall Salmonella
The U.S. United States — Food and Drug Administration (FDA) upgraded a recall of over 1.6 million cartons of eggs to Class 1, its highest risk level, due to potential Salmonella Enteritidis contamination. The eggs,…
Impact: Regulatory authority that upgraded the egg recall to Class 1 and is investigating the outbreaks; its actions drive the recall process.
Aug 14, 2026 · 6 articles
6 -40
Domestic
Trump nominates Heidi Overton to lead FDA
President Donald Trump nominated Dr. Heidi Overton, a White House domestic policy aide, to lead the U.S. United States — Food and Drug Administration (FDA). Overton, a physician and deputy director of the White House…
Impact: The FDA is the agency being led. It faces staff losses, morale issues, and policy controversies; Overton's nomination could exacerbate these challenges.
Aug 19, 2026 · 101 articles
4 60
Regulatory
FDA Authorizes Aletta Robotic Blood Draw Device
The U.S. United States — Food and Drug Administration (FDA) has granted marketing authorization to Vitestro for the Aletta, the first standalone robotic device capable of drawing blood from a patient's arm without hands-on operator…
Impact: The FDA granted marketing authorization to Vitestro for the Aletta device through the De Novo pathway, establishing special controls. This action reflects the FDA's commitment to advancing innovative medical devices and may enhance its reputation as a facilitator of technological progress in healthcare.
Aug 19, 2026 · 7 articles
4 -40
Regulatory
FDA Cleared AI Devices Lack Outcome Testing
A study published in PLOS on August 19, 2026, analyzed all 1,357 AI-based medical devices authorized by the U.S. United States — Food and Drug Administration (FDA) as of December 5, 2025. The researchers, led…
Impact: The FDA is the central regulator whose clearance process is criticized for not requiring outcome testing. The study could lead to policy changes affecting its approval pathways.
Aug 19, 2026 · 6 articles
7 70
Regulatory
FDA Panel Recommends Moderna mRNA Flu Vaccine
Impact: The United States — Food and Drug Administration (FDA) is the regulatory body responsible for approving the mFlusiva vaccine. Its advisory committee's unanimous recommendation is a crucial step towards the vaccine's market entry, despite internal disputes and leadership vacancies.
Jun 18, 2026 · 28 articles
6 0
Business
FDA Accepts Pharvaris Deucrictibant NDA
Impact: The United States — Food and Drug Administration accepted Pharvaris' New Drug Application for deucrictibant IR and set a PDUFA target action date of April 23, 2027. This action is a crucial step in the regulatory process for the drug's potential approval.
Jul 06, 2026 · 6 articles
4 0
Regulatory
Rosen Law Firm Investigates Disc Medicine
Rosen Law Firm is continuing its investigation into Disc Medicine, Inc. following a Complete Response Letter issued by the United States — Food and Drug Administration on February 13, 2026, concerning Disc Medicine's bitopertin program.…
Impact: The United States — Food and Drug Administration issued a Complete Response Letter to Disc Medicine, Inc. regarding its bitopertin program, citing uncertainties in the new drug application.
Apr 29, 2026 · 68 articles
4 0
Regulatory
Galderma RelabotulinumtoxinA U.S. FDA Delay
Impact: The United States — Food and Drug Administration issued a Complete Response Letter to Galderma Group for RelabotulinumtoxinA, citing observations during a manufacturing site inspection and analytical method optimization, which delays the product's approval in the United States.
Jul 01, 2026 · 6 articles
6 0
Regulatory
FDA Accepts Replimune RP1 BLA Resubmission
Impact: The United States — Food and Drug Administration accepted the resubmission of the Biologics License Application for RP1, setting a target action date and scheduling an advisory committee meeting, which are crucial steps in the regulatory process for Replimune Group's drug.
Jun 26, 2026 · 8 articles
4 0
Regulatory
Children's Ibuprofen Recall in US
Impact: The United States — Food and Drug Administration has issued an alert to Nigerians regarding the recall of Children's Ibuprofen Oral Suspension in the U.S. and is taking proactive measures to prevent its entry into the Nigerian market.
Jun 13, 2026 · 8 articles
4 0
Regulatory
Medicus Pharma Seeks SkinJect Designation
Impact: The United States — Food and Drug Administration is the regulatory body reviewing Medicus Pharma's applications for Skinject, including Rare Pediatric Disease Designation and Orphan Drug Designation, which are crucial for the drug's approval and market entry.
Jun 15, 2026 · 6 articles
6 -20
Domestic
Trump's Acetaminophen-Autism Link, Leucovorin Approval
Impact: The United States — Food and Drug Administration was directed by Donald Trump to issue new guidance on acetaminophen and approved leucovorin for autism treatment, facing scrutiny for its scientific basis.
Sep 22, 2025 · 6 articles
4 50
Regulatory
NAFDAC Assures Nestlé Nigeria Formula Safety
Impact: United States — Food and Drug Administration reassured the public that Nestlé infant formulae sold in Nigeria are safe and not part of the global recall initiated by Nestlé UK.
Jan 12, 2026 · 7 articles
4 0
Business
FDA Accepts Telix TLX101-Px NDA
Impact: The United States — Food and Drug Administration accepted Telix Pharmaceuticals' resubmitted New Drug Application for TLX101-Px, assigning a PDUFA goal date of September 11, 2026. This action moves the drug closer to potential approval for use in the United States.
Apr 09, 2026 · 6 articles
4 0
Regulatory
FDA Files Spectral Medical PMX PMA
Impact: The United States — Food and Drug Administration completed its filing review and formally filed Spectral Medical's Premarket Approval application for PMX, initiating the substantive review phase.
Jun 25, 2026 · 6 articles
6 0
Regulatory
Capricor Deramiocel FDA Advisory Meeting
Impact: The United States — Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee is convening a meeting to review Paragon Therapeutics' Biologics License Application for Deramiocel, which is a critical step in the regulatory approval process for the drug.
Jun 26, 2026 · 6 articles
4 0
Regulatory
FDA issues CRL for Sobi's NASP
Impact: The United States — Food and Drug Administration issued a Complete Response Letter to Swedish Orphan Biovitrum, requesting more data and facility improvements for National Association of Securities Professionals, thus impacting the drug's approval timeline.
Jun 26, 2026 · 6 articles
6 0
Tech
Artivion AMDS Prosthesis FDA Approval
Impact: The United States — Food and Drug Administration granted Premarket Approval (PMA) for Artivion's AMDS Hybrid Prosthesis, validating its safety and effectiveness and removing administrative barriers for its use in hospitals.
Jun 29, 2026 · 6 articles
4 0
Regulatory
STARMED Receives FDA Clearance
Impact: The United States — Food and Drug Administration granted 510(k) clearance to STARMED America for its thyroid-specific indication, enabling the company to market its devices for this application in the United States.
Jun 30, 2026 · 6 articles
+ 612 more events View on Dashboard
Key Actions (top 30 of 91)
100 United States — Food and Drug Administration issued warning letter United States — MedlinePlusMedline FDA violations...
100 United States — Food and Drug Administration approved ModernaFDA Approves Moderna's...
100 United States — Food and Drug Administration approved Takeda Pharmaceutical CompanyFDA Approves Takeda's...
100 United States — Food and Drug Administration released briefing documents Paragon TherapeuticsCapricor Deramiocel FDA...
100 United States — Food and Drug Administration released briefing documents Paragon TherapeuticsCapricor Deramiocel FDA...
100 United States — Food and Drug Administration cleared Samsung ElectronicsSamsung Galaxy Buds FDA...
100 United States — Food and Drug Administration inspected Aurisco PharmaceuticalAurisco passes USFDA...
100 United States — Food and Drug Administration approved Mapp BiopharmaceuticalFDA Approves ArkBio...
100 United States — Food and Drug Administration proposed reclassification PhotocureFDA Proposes Reclassifying...
100 United States — Food and Drug Administration approved Lupin (company)Lupin FDA Approval...
100 United States — Food and Drug Administration accepted NDA Sun PharmaFDA Accepts Teva Ecopipam NDA
100 United States — Food and Drug Administration approved modular PMA pathway Femasys Inc.FDA Approves FemBloc...
100 United States — Food and Drug Administration granted clearance Carl Zeiss MeditecZEISS CLINIC 360 FDA clearance
100 United States — Food and Drug Administration authorized VitestroFDA Authorizes Aletta...
100 United States — Food and Drug Administration granted premarket approval ImplanticaFDA approves Implantica...
100 United States — Food and Drug Administration clearedFDA Cleared AI Devices...
100 Implantica secured United States — Food and Drug AdministrationFDA approves Implantica...
99 United States — Food and Drug Administration denied Biologics License Application Paragon TherapeuticsCapricor Deramiocel FDA...
99 Paragon Therapeutics announced advisory meeting United States — Food and Drug AdministrationCapricor Deramiocel FDA...
97 Moderna sought approval United States — Food and Drug AdministrationFDA Approves Moderna's...
95 United States — Food and Drug Administration released briefing documents Paragon TherapeuticsCapricor Deramiocel FDA...
95 United States — Food and Drug Administration rejected BLA Replimune GroupReplimune Securities Class...
93 United States — Food and Drug Administration issued Complete Response Letter Disc MedicineRosen Law Firm...
92 United States — Food and Drug Administration placed clinical hold MiNK TherapeuticsAardvark Therapeutics...
90 United States — Food and Drug Administration concluded malignancy risk Fulcrum TherapeuticsFulcrum Therapeutics drug...
90 United States — Food and Drug Administration proposed rule changeFDA proposes mandatory...
90 United States — Food and Drug Administration granted clearance Bracco S.p.A. — Bracco ImagingBracco VueJect FDA and...
90 United States — Food and Drug Administration upgraded recall to Class 1 Midwest Poultry ServicesFDA Class 1 Egg Recall Salmonella
90 United States — Food and Drug Administration accepted application GT BiopharmaHansa Biopharma first...
90 United States — Food and Drug Administration provided pre-IND feedback AnBogen TherapeuticsFDA pre-IND feedback for PT00114
+ 61 more actions View on Dashboard
Relationships (364)
Applied Therapeutics ↔ United States — Food and Drug Administration
Applied Therapeutics regulated ↔ United States — Food and Drug Administration Applied Therapeutics is a biopharmaceutical company strictly regulated by the FD
Viatris ↔ United States — Food and Drug Administration
Viatris ↔ United States — Food and Drug Administration
United States — Centers for Disease Control and Prevention ↔ United States — Food and Drug Administration
United States — Centers for Disease Control and Prevention ↔ United States — Food and Drug Administration
PepGen ↔ United States — Food and Drug Administration
PepGen ↔ United States — Food and Drug Administration
Rocket Pharmaceuticals ↔ United States — Food and Drug Administration
Rocket Pharmaceuticals ↔ United States — Food and Drug Administration
Savara ↔ United States — Food and Drug Administration
Dexcom ↔ United States — Food and Drug Administration
Savara ↔ United States — Food and Drug Administration
Dexcom ↔ United States — Food and Drug Administration
Kenvue ↔ United States — Food and Drug Administration
Unicycive Therapeutics ↔ United States — Food and Drug Administration
American College of Obstetricians and Gynecologists ↔ United States — Food and Drug Administration
Publix ↔ United States — Food and Drug Administration
Kenvue ↔ United States — Food and Drug Administration
Unicycive Therapeutics ↔ United States — Food and Drug Administration
American College of Obstetricians and Gynecologists ↔ United States — Food and Drug Administration
Publix ↔ United States — Food and Drug Administration
United States — National Park Service ↔ United States — Food and Drug Administration
United States — National Park Service ↔ United States — Food and Drug Administration
Actinium Pharmaceuticals ↔ United States — Food and Drug Administration
Actinium Pharmaceuticals ↔ United States — Food and Drug Administration
UniQure ↔ United States — Food and Drug Administration
UniQure ↔ United States — Food and Drug Administration
United States — Medicare ↔ United States — Food and Drug Administration
United States — Medicare ↔ United States — Food and Drug Administration
+ 334 more relationships View on Dashboard
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