United States & United States — Food and Drug Administration
96 shared events · Importance 21 · Last updated Jul 06, 2026
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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 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 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
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
Tech
United States: The United States is the primary market for the Lyme disease vaccine, with a significant and expanding incidence of the disease. Regulatory approval within the United States, particularly from the United States — Food and Drug Administration, is crucial for the vaccine's availability.
United States — Food and Drug Administration: 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
Domestic
United States: The United States is involved in a fragile truce with Iran and its economy is showing slower-than-expected growth and elevated consumer prices, leading to potential interest rate hikes by the United States — Federal Reserve.
United States — Food and Drug Administration: The United States — Food and Drug Administration approved Eli Lilly and Company's weight loss pill, Foundayo, impacting the pharmaceutical market.
Apr 01, 2026 · 14 articles
Regulatory
United States: The United States government, through its Justice Department and other agencies, successfully prosecuted Alibaba Group and AUS Merchant Services for violations of federal law, protecting American consumers from illegal pharmaceuticals.
United States — Food and Drug Administration: The United States — Food and Drug Administration was involved in the investigation, with its law enforcement officers conducting undercover purchases of illegal pharmaceuticals and equipment.
Jul 01, 2026 · 23 articles
Regulatory
United States: The United States is the market where the drug National Association of Securities Professionals is seeking approval from the United States — Food and Drug Administration, affecting patients with gout in this country.
United States — Food and Drug Administration: 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
Business
United States: The United States is the target market for Grey Matters Health Inc.'s expansion of neuroimaging clinics, addressing a growing demand for Alzheimer's detection and treatment within the country.
United States — Food and Drug Administration: The United States — Food and Drug Administration has cleared the CareMiBrain system for use and has approved new monoclonal antibody treatments for Alzheimer's Disease, creating a market for the PET scans.
Jul 06, 2026 · 6 articles
Business
United States: The acquisition establishes a significant biologics manufacturing platform within the United States, addressing evolving regulatory and supply chain dynamics and reducing offshore dependency for biotech and pharmaceutical companies.
United States — Food and Drug Administration: The acquired facilities have completed multiple United States — Food and Drug Administration inspections with clean results, indicating compliance with regulatory standards.
Jul 02, 2026 · 7 articles
Tech
United States: The United States is a key market for the Sweden — Stockholm test, with Haier Biomedical planning to seek FDA approval and generate U.S. data to support its pathway.
United States — Food and Drug Administration: The United States — Food and Drug Administration's approval is necessary for the Sweden — Stockholm test to be routinely available in the United States, making it a critical regulatory body for Haier Biomedical's market entry.
Jun 26, 2026 · 6 articles
Tech
United States: The United States is the primary market for Altor BioScience' drug, and the opioid crisis within the United States is the problem that Altor BioScience is trying to solve.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted Breakthrough Therapy designation to PF614-MPAR, which highlights the potential importance of Altor BioScience' drug.
Jun 26, 2026 · 6 articles
Business
United States: The United States is the primary market for the commercial launch of Modular Medical's Pivot tubeless insulin patch pump, with plans for expansion across select metropolitan markets.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted 510(k) clearance for Modular Medical's Pivot tubeless insulin patch pump in April 2026, which paved the way for the commercial rollout of the device.
Jun 04, 2026 · 20 articles
Business
United States: The United States is mentioned as a region where Nestlé has already eliminated artificial colorings from its portfolio, indicating a precedent for its global initiative and highlighting the influence of consumer and regulatory trends in this market.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) has expressed concerns about artificial food colorings and aims to remove them, providing a regulatory backdrop that influences companies like Nestlé to make such changes. The FDA's stance validates Nestlé's initiative, although more research is needed on the health links.
Apr 20, 2026 · 20 articles
Tech
United States: The United States Food and Drug Administration approved the RSVpreF vaccine in 2023, and the United States — Centers for Disease Control and Prevention provides statistics on RSV hospitalizations, highlighting the public health relevance of the vaccine within the nation.
United States — Food and Drug Administration: The United States — Food and Drug Administration approved the RSVpreF vaccine in 2023, which is a prerequisite for its widespread use and impact on public health.
Jun 05, 2026 · 7 articles
Regulatory
United States: The United States is a target for a Biologics License Application (BLA) submission in early 2027 for INmune Bio Inc.'s CORDStrom platform, indicating future regulatory efforts in the country.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is a target for a Biologics License Application (BLA) submission in early 2027 for INmune Bio Inc.'s CORDStrom platform, indicating future regulatory efforts in the United States. The FDA also granted Fast Track designation for XPro1595.
Jun 25, 2026 · 6 articles
Regulatory
United States: Spectral Medical obtained exclusive development and commercial rights for PMX in the United States.
United States — Food and Drug Administration: 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
Tech
United States: The United States is the primary market where Melatonin is sold over-the-counter without strict regulation, impacting a significant portion of its population.
United States — Food and Drug Administration: The United States — Food and Drug Administration's lack of regulation over supplements like Melatonin is highlighted as a concern, leading to variability in dosage and purity.
Nov 03, 2025 · 9 articles
Business
United States: The United States is highlighted as the largest pharmaceutical market globally, making it a key focus for EirGenix's expansion and partnership discussions.
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned as a regulatory agency whose harmonized frameworks are streamlining biosimilar approval pathways, benefiting companies like EirGenix.
Jun 30, 2026 · 6 articles
Business
United States: The Australia — Australian dollar amount of the capital raise was also reported in United Statess, approximately US$2.59 million.
United States — Food and Drug Administration: The United States — Food and Drug Administration cleared Imagion Biosystems' IND application for a Phase 2 clinical trial, a key milestone that enabled the company to secure new capital.
Jun 25, 2026 · 6 articles
Domestic
United States: The United States is the nation where the podcast is being launched by a government agency, aiming to address health policy and voter concerns.
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned as having a commissioner, Marty Makary, who also hosts a podcast, providing context for the novelty of a cabinet secretary hosting one.
Apr 08, 2026 · 15 articles
Tech
United States: The Zeta Navigation System and Zeta TMS Navigation System are commercially available in the United States, indicating the market where these treatments are being deployed.
United States — Food and Drug Administration: The United States — Food and Drug Administration cleared the Zeta TMS Navigation System, which is a prerequisite for its commercial use in the United States.
Jun 25, 2026 · 6 articles
Business
United States: Pfizer — Trillium Therapeutics operates within the United States' third-largest biopharma hub, and its LAMair" test is available nationwide, indicating the national scope of this healthcare initiative.
United States — Food and Drug Administration: The United States — Food and Drug Administration's approval of Rapamune in 2015 as the first effective treatment for LAM, based on research supported by LAM Foundation, is mentioned as a historical context for advancements in LAM treatment.
Jun 29, 2026 · 7 articles
Tech
United States: The United States is mentioned as a country where the drug POTELIGEO is indicated for treatment, and where adverse reactions can be reported to the FDA.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is the regulatory body in the U.S. to which suspected adverse reactions to POTELIGEO are encouraged to be reported.
Jun 29, 2026 · 7 articles
Tech
United States: The U.S. indication for POTELIGEO (mogamulizumab-kpkc) is mentioned, indicating the drug's availability and regulatory status in the country.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is mentioned as an entity to which suspected adverse reactions to POTELIGEO can be reported.
Jun 30, 2026 · 6 articles
Tech
United States: The PRESERVE study plans to enroll approximately 150 patients across approximately 50 sites in the United States.
United States — Food and Drug Administration: The United States — Food and Drug Administration previously approved LUPKYNIS as an oral therapy for lupus nephritis.
Jul 06, 2026 · 6 articles
Domestic
United States — Food and Drug Administration: The United States — Food and Drug Administration is one of the agencies occupying offices whose leases were initially slated for termination by the Department of Government Efficiency (DOGE) but have since been spared.
Sep 23, 2025 · 10 articles
Domestic
United States — Food and Drug Administration: 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
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