United States & United States — Food and Drug Administration
242 shared events · Importance 32 · Last updated Aug 24, 2026
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Accidents
United States: The United States is the country affected by the outbreak, with cases in nearly all states. The outbreak has raised concerns about food safety and public health infrastructure.
United States — Food and Drug Administration: 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
Regulatory
United States: The U.S. is the primary market for Galleri, and FDA approval would enable commercial launch, impacting public health and healthcare costs.
United States — Food and Drug Administration: The FDA is the regulatory authority reviewing the PMA application. Its decision will determine Galleri's market availability in the U.S.
Aug 07, 2026 · 6 articles
Accidents
United States: Country experiencing widespread outbreak affecting public health and food safety.
United States — Food and Drug Administration: The FDA is assisting in the outbreak investigation, focusing on food safety and potential contamination sources.
Jun 30, 2026 · 348 articles
Regulatory
United States: The United States market entry for Galderma Group's RelabotulinumtoxinA is delayed due to the United States — Food and Drug Administration's Complete Response Letter, impacting the availability of the product in this key market.
United States — Food and Drug Administration: 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
Regulatory
United States: The U.S. gains a new flu vaccine option, potentially improving public health outcomes for older adults.
United States — Food and Drug Administration: 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
Regulatory
United States: The U.S. is the target market for Nipro's ELISIO-HX dialyzer, representing a large dialysis patient population.
United States — Food and Drug Administration: The FDA granted 510(k) clearance to Nipro's ELISIO-HX dialyzer, a routine regulatory action.
Jul 30, 2026 · 7 articles
Regulatory
United States: The United States represents the world's largest medical device market and a substantial growth opportunity for Implantica. The approval allows the company to address an estimated 78 million Americans suffering from acid reflux.
United States — Food and Drug Administration: The FDA granted Premarket Approval for RefluxStop after reviewing long-term clinical evidence, affirming the device's safety and effectiveness. This regulatory action is a key enabler for Implantica's U.S. launch.
Aug 20, 2026 · 16 articles
Regulatory
United States: The United States market is significantly impacted by this FDA clearance, as it introduces a new, minimally invasive treatment option for thyroid nodules for its population.
United States — Food and Drug Administration: 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
Regulatory
United States: The United States>>> market now has the first approved treatment for chronic hepatitis delta virus, addressing a significant public health need for an estimated 40,000 to 80,000 people.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> granted accelerated approval to Hepcludex, making it the first approved treatment for chronic hepatitis delta virus in the United States>>>. This action addresses a critical unmet medical need.
May 22, 2026 · 10 articles
Regulatory
United States: The FDA is a U.S. agency, and the study affects U.S. consumers and tampon manufacturers. The U.S. market for tampons remains stable.
United States — Food and Drug Administration: 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
Regulatory
United States: The U.S. food supply and public health are directly affected by the proposed regulations.
United States — Food and Drug Administration: 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
Regulatory
United States: The FDA's regulatory framework is under scrutiny; the study could influence US healthcare policy.
United States — Food and Drug Administration: 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
Regulatory
United States: The United States market for Tofacitinib Tablets is estimated at $500 million, representing a significant opportunity for Concord Biotech.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted approval for Concord Biotech's Tofacitinib Tablets, enabling the company to market the drug in the US.
Jun 10, 2026 · 6 articles
Accidents
United States: The outbreak affects public health across 15 states, prompting federal and state responses. It may lead to increased food safety regulations and consumer awareness.
United States — Food and Drug Administration: The FDA posted the recall notice and is investigating the outbreak, reinforcing its regulatory role in food safety. The agency's actions may lead to increased scrutiny of sprout producers.
Aug 21, 2026 · 14 articles
Regulatory
United States: The United States is the primary market for the mFlusiva vaccine, with tens of thousands of Americans dying from influenza annually. The approval of this mRNA vaccine could significantly impact public health strategies and pandemic preparedness within the country.
United States — Food and Drug Administration: 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
Domestic
United States: The U.S. faces a measles outbreak and declining vaccination rates. The executive order could worsen public health outcomes and create international concern about vaccine policy.
United States — Food and Drug Administration: The FDA would need to approve any new separate vaccines, a process that could take years. The executive order may increase its workload and regulatory scrutiny.
Aug 23, 2026 · 8 articles
Business
United States: The United States is the target market for Telix Pharmaceuticals' TLX101-Px, with the United States — Food and Drug Administration's acceptance of the NDA being a crucial step towards making the product available to patients and clinicians in the country.
United States — Food and Drug Administration: 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
Regulatory
United States: The United States>>> is the market where the United States — Food and Drug Administration>>> accepted the BLA for AVT16, potentially expanding biosimilar options for patients and healthcare providers.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted the Biologics License Application for AVT16, initiating the review process for this proposed interchangeable biosimilar.
Jun 08, 2026 · 11 articles
Tech
United States: The expanded approval of HYMPAVZI>>> by the United States — Food and Drug Administration>>> directly impacts the healthcare market and patients within the United States>>>.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> granted the expanded approval for HYMPAVZI, validating its efficacy and safety for a broader patient population. This action reflects the agency's role in regulating and approving pharmaceutical products in the United States>>>.
Jun 08, 2026 · 7 articles
Regulatory
United States: The U.S. is the primary market for the FDA-cleared feature, with availability in select approved markets, impacting U.S. consumers with hearing loss.
United States — Food and Drug Administration: The FDA granted clearance, enabling Samsung to market the feature as an OTC hearing aid, reinforcing its role as a regulator of medical devices.
Aug 11, 2026 · 22 articles
Domestic
United States: The country faces a public health crisis with falling vaccination rates and a major measles outbreak, exacerbated by this policy.
United States — Food and Drug Administration: Responsible for approving any new separate vaccines, a process that could take years. It faces pressure to review unbundled shots without precedent.
Aug 10, 2026 · 235 articles
Business
United States: The United States is Jyong Biotech's primary target market for FDA approval and commercialization, which is crucial for its global regulatory and pricing strategy.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) approval is a critical milestone for Jyong Biotech's lead drug candidates, as it enables market access and sets a precedent for global regulatory pathways.
May 29, 2026 · 7 articles
Business
United States: Market where Leqembi Iqlik is now available; patients gain at-home treatment option.
United States — Food and Drug Administration: Approved Leqembi Iqlik on July 13, enabling the US launch.
Aug 24, 2026 · 6 articles
Domestic
United States: The United States, as the nation whose military is affected, sees this as a domestic policy change with no direct international implications. The policy reflects the Trump administration's health and readiness priorities.
United States — Food and Drug Administration: The FDA proposed easing prescribing limits on testosterone products and removed a boxed warning on heart risks, facilitating broader use. These regulatory changes complement the military screening policy.
Jul 15, 2026 · 109 articles
Tech
United States: The United States>>> was the location of the U.S.-led study of daraxonrasib and the initial application for drug licensing to the United States — Food and Drug Administration>>>.
United States — Food and Drug Administration: The United States — Food and Drug Administration is expediting the review of daraxonrasib and has allowed expanded access to the drug, indicating its critical role in bringing this new treatment to patients.
May 29, 2026 · 74 articles
Business
United States: The United States>>> is the target market for the biosimilar applications, with the United States — Food and Drug Administration>>> (FDA) being the regulatory authority for approval.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> (FDA) is the regulatory body reviewing Alvogen's resubmitted applications for AVT05 and AVT06. Their decision will determine the market entry of these biosimilars in the United States>>>.
Jun 04, 2026 · 10 articles
Tech
United States: The United States is the market where the United States — Food and Drug Administration's clearance allows GE HealthCare's software to be used, impacting over 2 million U.S. patients annually who receive radiation therapy.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted 510(k) clearance to GE HealthCare's MIM Contour ProtégéAI+ 2.0, enabling the software's use in the United States market for radiation oncology treatment planning.
Jun 04, 2026 · 6 articles
Regulatory
United States: The U.S. FDA granted approval, impacting the domestic IgAN patient population of about 160,000.
United States — Food and Drug Administration: The FDA granted accelerated approval for TRUTAKNA based on proteinuria reduction, with continued approval contingent on confirmatory data.
Jul 07, 2026 · 6 articles
Regulatory
United States: The US is the target market for the NDA; approval would make CAM2029 available to US patients with acromegaly.
United States — Food and Drug Administration: The FDA accepted the resubmission for review and set a PDUFA date; its regulatory decision will determine market access for CAM2029 in the US.
Jul 17, 2026 · 6 articles
Regulatory
United States: The U.S. is the primary market for the regulatory submission.
United States — Food and Drug Administration: The FDA accepted the application for Priority Review and will decide by Q4 2026.
Jul 22, 2026 · 6 articles
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