Snapshot from Jul 07, 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 289 events · 4336 articles · First seen Jan 04, 2025 · Last active Jul 06, 2026

Sentiment
2
Attention
9
Events
289
Relationships
282
Live sentiment trends, attention charts, and prominence tracking available on the Ergen Dashboard
Events (top 30 of 289)
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
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
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 · 20 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
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
4 0
Regulatory
Lupin gets US FDA approval
Impact: The United States — Food and Drug Administration granted tentative approval for Lupin (company)'s Enzalutamide Tablets, acting as the regulatory body overseeing drug approvals in the U.S.
Jun 26, 2026 · 16 articles
4 0
Regulatory
Amgen Recalls Corlanor, Sensipar Tablets
Impact: The United States — Food and Drug Administration characterized the medication recall as Class II and is overseeing the recall process initiated by Amgen, ensuring public safety and regulatory compliance.
Jun 27, 2026 · 6 articles
4 60
Tech
Alpha-Gal Syndrome Cases Rise, New Treatments
Impact: The United States — Food and Drug Administration approved Omalizumab in 2024 for food allergies, including alpha-gal syndrome, and previously approved genetically modified pigs for consumption in 2020, which are significant regulatory actions impacting treatment and food sources for those with alpha-gal syndrome.
Jun 13, 2026 · 9 articles
4 0
Regulatory
Teva Recalls Prazosin Hydrochloride Capsules
Impact: The United States — Food and Drug Administration classified the recall as Class II and is overseeing the process, ensuring patient safety and regulatory compliance.
Oct 29, 2025 · 8 articles
4 10
Accidents
Nate's Fine Foods Listeria Outbreak
Impact: The United States — Food and Drug Administration is actively investigating the listeria outbreak, issuing notices, and coordinating recalls to protect public health.
Oct 13, 2025 · 6 articles
4 0
Regulatory
Sonoma Pharmaceuticals gets FDA clearance
Impact: The United States — Food and Drug Administration granted 510(k) clearance to Sonoma Pharmaceuticals for its Microdacyn Wound Irrigation Solution, allowing expanded claims and uses for the product.
Jun 30, 2026 · 6 articles
4 20
Regulatory
Utz Recalls Zapp's, Dirty Chips
Impact: The United States — Food and Drug Administration classified the recall of Zapp s and Dirty brand potato chips as a Class I recall, its highest risk category, indicating a serious health risk to consumers. This action highlights its role in public health protection.
Jul 01, 2026 · 7 articles
6 0
Tech
Pfizer, Valneva Seek Lyme Vaccine Approval
Impact: The United States — Food and Drug Administration (FDA) is the regulatory body responsible for approving the Lyme disease vaccine developed by Pfizer and Valneva SE. Its approval is essential for the vaccine to become available to the public.
Apr 30, 2026 · 20 articles
4 -20
Tech
Food Preservatives Linked to Hypertension
Impact: United States — Food and Drug Administration>>> is a regulatory body in the USA that the study's authors urged to reconsider additive safety evaluations in light of the new findings.
May 20, 2026 · 20 articles
6 0
Regulatory
Utah AI Prescription Refill Debate
Impact: The United States — Food and Drug Administration (FDA) is the federal agency responsible for overseeing AI that impacts medical care, but it has taken a hands-off approach to Doctronic's program.
Jul 06, 2026 · 14 articles
4 0
Regulatory
Medline_Industries securities fraud investigation
Impact: The United States — Food and Drug Administration issued a warning letter to JK Industries for significant violations of Current Good Manufacturing Practice regulations, which triggered the investigation and stock price drop.
Jun 16, 2026 · 6 articles
4 0
Business
Biohaven Ltd. Securities Class Action
Impact: The United States — Food and Drug Administration extended the PDUFA date for Biohaven Pharmaceutical Holding Company's troriluzole new drug application and is planning an advisory committee meeting, which led to a significant drop in Biohaven Pharmaceutical Holding Company's stock price.
Jul 25, 2025 · 6 articles
6 -30
Domestic
Trump Links Tylenol, Vaccines to Autism
Impact: The United States — Food and Drug Administration is expected to notify doctors about a potential association between acetaminophen and autism, a recommendation that lacks immediate medical evidence and is controversial.
Sep 22, 2025 · 6 articles
6 70
Tech
UniQure's Gene Therapy Slows Huntington's
Impact: The United States — Food and Drug Administration is the regulatory body to which UniQure plans to submit its marketing application for AMT-130, with potential approval leading to the therapy's launch.
Sep 24, 2025 · 6 articles
2 0
Regulatory
Neutrogena Makeup Wipes Bacterial Recall
Impact: The United States — Food and Drug Administration assigned a Class II risk level to the recall, overseeing the process and informing the public about the potential health risks.
Oct 24, 2025 · 9 articles
2 0
Regulatory
Savara Class Action Over MOLBREEVI BLA
Impact: The United States — Food and Drug Administration issued a refusal to file letter for Savara's MOLBREEVI BLA, citing insufficient information, which triggered the stock price drop and subsequent lawsuit.
Oct 06, 2025 · 6 articles
+ 259 more events View on Dashboard
Key Actions (top 30 of 60)
100 United States — Food and Drug Administration accepted resubmission Replimune GroupFDA Accepts Replimune RP1...
100 United States — Food and Drug Administration granted tentative approval Lupin (company)Lupin gets US FDA approval
100 United States — Food and Drug Administration launched campaign NigeriaNAFDAC Launches 'Read Food...
100 United States — Food and Drug Administration issued Complete Response Letter Swedish Orphan BiovitrumFDA issues CRL for Sobi's NASP
100 United States — Food and Drug Administration approved application AMDS Hybrid ProsthesisArtivion AMDS Prosthesis...
100 United States — Food and Drug Administration granted 510(k) clearance Sonoma PharmaceuticalsSonoma Pharmaceuticals...
100 United States — Food and Drug Administration issued Complete Response Letter Galderma GroupGalderma...
100 United States — Food and Drug Administration granted clearance STARMED AmericaSTARMED Receives FDA Clearance
100 United States — Food and Drug Administration accepted New Drug Application PharvarisFDA Accepts Pharvaris...
100 Paragon Therapeutics announced advisory meeting United States — Food and Drug AdministrationCapricor Deramiocel FDA...
95 United States — Food and Drug Administration debated vaccine ModernaFDA Panel Recommends...
95 Moderna sought approval United States — Food and Drug AdministrationFDA Panel Recommends...
90 United States — Food and Drug Administration issued Complete Response Letter Disc MedicineRosen Law Firm...
90 United States — Food and Drug Administration announced recall Utz BrandsUtz Recalls Zapp's, Dirty Chips
90 United States — Food and Drug Administration approved drug OmalizumabAlpha-Gal Syndrome Cases...
90 United States — Food and Drug Administration published warning letter JK IndustriesMedline_Industries...
90 Oculis will not pursue filing United States — Food and Drug AdministrationOculis OCS-01 trial...
90 Modular Medical received clearance United States — Food and Drug AdministrationModular Medical Launches...
90 Quantum BioPharma submitted application United States — Food and Drug AdministrationQuantum BioPharma Advances...
90 Artivion announced approval United States — Food and Drug AdministrationArtivion AMDS Prosthesis...
85 Caris Life Sciences delayed FDA clearance United States — Food and Drug AdministrationTriSalus Securities Fraud...
80 United States — Food and Drug Administration warned Knight Therapeutics Knight TherapeuticsKuehn Law Investigates...
80 United States — Food and Drug Administration approved consumptionAlpha-Gal Syndrome Cases...
80 United States — Food and Drug Administration published favorable review ModernaFDA Panel Recommends...
80 United States — Food and Drug Administration will discuss ModernaMedera SRD-002 HFpEF Trial Advances
80 United States — Food and Drug Administration granted designation Altor BioScienceEnsysce Biosciences...
80 United States — Food and Drug Administration cleared application Imagion BiosystemsImagion Biosystems Secures AU$3.75M
80 United States — Food and Drug Administration conducted Pre-License Inspection Galderma GroupGalderma...
80 Swedish Orphan Biovitrum will request meeting United States — Food and Drug AdministrationFDA issues CRL for Sobi's NASP
70 United States — Food and Drug Administration assigned risk levelAmgen Recalls Corlanor,...
+ 30 more actions View on Dashboard
Relationships (282)
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
European Union — European Medicines Agency ↔ United States — Food and Drug Administration
European Union — European Medicines Agency ↔ United States — Food and Drug Administration
Marty Makary ↔ United States — Food and Drug Administration
Marty Makary ex-commissioner ↔ United States — Food and Drug Administration Marty Makary served as the Commissioner of the Food and Drug Administration for
PepGen ↔ United States — Food and Drug Administration
PepGen ↔ United States — Food and Drug Administration
Rocket Pharmaceuticals ↔ United States — Food and Drug Administration
Replimune Group ↔ United States — Food and Drug Administration
Rocket Pharmaceuticals ↔ United States — Food and Drug Administration
Replimune Group ↔ United States — Food and Drug Administration
Paragon Therapeutics ↔ United States — Food and Drug Administration
Paragon Therapeutics ↔ 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
Joseph E. Levi ↔ United States — Food and Drug Administration
Joseph E. Levi ↔ 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
+ 252 more relationships View on Dashboard
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