United States — Food and Drug Administration
Tracked across 243 events · 2478 articles · First seen Jan 04, 2025 · Last active May 28, 2026
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Regulatory
The United States — Food and Drug Administration has announced significant steps to modernize its operations by launching Elsa 4.0, an upgraded internal AI tool, and consolidating over 40 disparate data sources into a new…
Impact: The United States — Food and Drug Administration launched Elsa 4.0 and consolidated data into HALO, significantly modernizing its operations and enhancing its ability to review and approve medical products.
May 06, 2026 · 7 articles
Domestic
Marty Makary resigned as Commissioner of the United States — Food and Drug Administration on May 12, 2026, after a contentious 13-month tenure. His departure followed sustained pressure from within the Donald Trump administration and…
Impact: The United States — Food and Drug Administration is experiencing a leadership change with the resignation of its Commissioner, Marty Makary, and the appointment of Kyle Diamantas as acting chief. The agency has faced internal clashes, policy confusion, and criticism during Marty Makary's tenure.
May 08, 2026 · 35 articles
Domestic
Dr. Marty Makary resigned as the head of the United States — Food and Drug Administration (FDA) after a turbulent 13-month tenure, marked by internal conflicts, mass layoffs, and a series of controversies. His departure…
Impact: The United States — Food and Drug Administration experienced significant leadership turnover, low staff morale, and unpredictable regulatory shifts under Marty Makary's leadership, leading to uncertainty for regulated industries.
May 12, 2026 · 32 articles
Regulatory
Tracy Beth Høeg, the acting head of the United States — Food and Drug Administration's drug center, is expected to leave the agency shortly after Commissioner Marty Makary resigned. This departure is part of a…
Impact: The United States — Food and Drug Administration is undergoing a significant shake-up with the departure of key officials like Tracy Beth Høeg and Marty Makary, and the United States — White House exerting more control over its policies.
May 15, 2026 · 6 articles
Regulatory
Dr. Tracy Beth Høeg, acting drug center director at the United States — Food and Drug Administration, was removed from her position, following her controversial inquiries into the safety of antidepressants and COVID-19 vaccines. This…
Impact: The United States — Food and Drug Administration is experiencing significant leadership changes, including the removal of Tracy Beth Høeg and the resignation of Marty Makary and Vinay Prasad, which could impact its regulatory direction and stability.
May 16, 2026 · 10 articles
Domestic
President Donald Trump>>> has signed off on a plan to fire Marty Makary>>>, the Commissioner of the United States — Food and Drug Administration>>>. This decision follows a series of controversies and criticisms against Marty…
Impact: The United States — Food and Drug Administration>>> is the agency undergoing a significant leadership change with the planned ouster of its Commissioner Marty Makary>>>, which has led to low morale and high-profile departures.
May 08, 2026 · 7 articles
Regulatory
The United States — Food and Drug Administration has extended the review period for Eisai's supplemental Biologics License Application (sBLA) for Lecanemab Iqlik, a once-weekly subcutaneous injection of lecanemab irmb for early Alzheimer's disease. The…
Impact: The United States — Food and Drug Administration extended the review period for the supplemental Biologics License Application for Lecanemab Iqlik, setting a new PDUFA date.
May 08, 2026 · 13 articles
Domestic
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
Regulatory
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
Business
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
Domestic
Dr. Marty Makary resigned as Commissioner of the United States — Food and Drug Administration on Tuesday, following widespread reports of his impending firing. President Donald Trump confirmed the resignation and appointed Kyle Diamantas as…
Impact: The United States — Food and Drug Administration is undergoing a leadership change with Marty Makary's resignation and Kyle Diamantas taking over as acting commissioner, potentially signaling shifts in regulatory policy.
May 12, 2026 · 8 articles
Business
Pomerantz LLP has filed a class action lawsuit against Atara Biotherapeutics and certain officers in the United States — United States District Court for the Northern District of California. The lawsuit alleges that Atara Biotherapeutics…
Impact: The United States — Food and Drug Administration issued Complete Response Letters and placed a clinical hold on Atara Biotherapeutics' Investigational New Drug applications, citing manufacturing issues and deficiencies in the ALLELE study, which directly impacted the company's stock price and led to the class action.
May 01, 2026 · 6 articles
Regulatory
Datar Cancer Genetics announced that its tissue-based comprehensive genomic profiling (CGP) assay for all solid tumors, CellDx-Tissue, has been cleared by the United States — Food and Drug Administration. This clearance strengthens Datar Cancer Genetics'…
Impact: The United States — Food and Drug Administration granted clearance for Datar Cancer Genetics' CellDx-Tissue assay, validating its scientific rigor and quality systems.
May 14, 2026 · 7 articles
Tech
Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca, has received two new approvals from the United States — Food and Drug Administration. These approvals are for the neoadjuvant…
Impact: The United States — Food and Drug Administration approved Trastuzumab deruxtecan for two new breast cancer indications, enabling its use in neoadjuvant and adjuvant settings.
May 15, 2026 · 9 articles
Regulatory
A federal appeals court, the United States — United States Court of Appeals for the Third Circuit, has restricted access to Mifepristone, a widely used abortion pill, by blocking its distribution via mail. The unanimous…
Impact: The United States — Food and Drug Administration's regulations allowing mail-order mifepristone were overruled by the United States — United States Court of Appeals for the Third Circuit, despite the agency's long-standing judgments on drug safety.
May 01, 2026 · 78 articles
Domestic
Justice Samuel Alito of the United States — Supreme Court of the United States temporarily halted an appellate court order that blocked a United States — Food and Drug Administration rule allowing the abortion pill…
Impact: The United States — Food and Drug Administration's rule allowing mifepristone to be prescribed online and dispensed through the mail was temporarily halted by an appellate court, but later paused by the United States — Supreme Court of the United States. The agency is conducting a safety review of mifepristone.
May 04, 2026 · 6 articles
Regulatory
ImmunityBio, a biotechnology company, is facing multiple securities class action lawsuits, initially filed by Rosen Law Firm and further investigated by Hagens Berman. The lawsuits allege that ImmunityBio and its executive chairman, Patrick Soon-Shiong, made…
Impact: The United States — Food and Drug Administration sent a warning letter to ImmunityBio regarding misleading efficacy claims made about Anktiva, which triggered the class action lawsuits.
Apr 02, 2026 · 42 articles
Regulatory
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
Accidents
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
Tech
Cellenkos, a clinical-stage biotechnology company, announced that the United States — Food and Drug Administration has cleared its Investigational New Drug (IND) application for CK0802. This clearance allows Cellenkos to initiate a Phase 1b/2a clinical…
Impact: The United States — Food and Drug Administration cleared Cellenkos's Investigational New Drug application for CK0802, enabling the initiation of a Phase 1b/2a clinical trial.
May 04, 2026 · 7 articles
Regulatory
U.S. Health Secretary Robert F. Kennedy Jr. and officials from the United States — United States Department of Health and Human Services explored the possibility of banning certain Selective serotonin reuptake inhibitor (SSRI) antidepressants, including…
Impact: The United States — Food and Drug Administration has authority over drug use and would need strong scientific evidence to impose new restrictions or bans on SSRIs, and can request drug withdrawals, but companies can refuse.
May 08, 2026 · 6 articles
Tech
The United States — Food and Drug Administration has approved a label expansion for Argenx's drugs, Efgartigimod alfa/hyaluronidase and Efgartigimod alfa/hyaluronidase, to include all adult patients living with generalized myasthenia gravis (gMG), regardless of serotype.…
Impact: The United States — Food and Drug Administration approved the label expansion for Argenx's drugs Efgartigimod alfa/hyaluronidase and Efgartigimod alfa/hyaluronidase, enabling broader treatment options for gMG patients.
May 08, 2026 · 6 articles
Regulatory
ImmunityBio, Inc. is facing a securities class action lawsuit initiated by Kahn Swick & Foti, LLC, following a 21% decline in its stock price. The decline occurred after the United States — Food and Drug…
Impact: The United States — Food and Drug Administration issued a warning letter to ImmunityBio, Inc. regarding misleading promotional communications for Anktiva, which led to the company's stock decline and subsequent lawsuit.
May 01, 2026 · 7 articles
Domestic
The United States — United States Department of Health and Human Services is facing significant leadership instability, with several key positions, including the U.S. surgeon general, head of the United States — Centers for Disease…
Impact: The United States — Food and Drug Administration faces a leadership void after Marty Makary's resignation, leaving unfinished initiatives and ongoing reviews under scrutiny. Its ability to balance regulatory interests with new health policies is challenged.
May 13, 2026 · 6 articles
Tech
The United States — Food and Drug Administration has approved Trastuzumab deruxtecan, a drug jointly developed and commercialized by AstraZeneca and Daiichi Sankyo, for two new indications in the treatment of HER2-positive early breast cancer.…
Impact: The United States — Food and Drug Administration granted approval for Trastuzumab deruxtecan for new indications in HER2-positive early breast cancer, enabling its broader use in the United States.
May 15, 2026 · 7 articles
Regulatory
Impact: The United States — Food and Drug Administration announced the recall and provided guidance to consumers, playing a crucial regulatory role in public health and food safety.
Apr 10, 2025 · 6 articles
Regulatory
Impact: The United States — Food and Drug Administration was notified of the recall and is investigating the incident, overseeing the safety of food products in the United States.
May 13, 2025 · 6 articles
Business
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
Domestic
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
Tech
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
+ 213 more events
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United States — Food and Drug Administration cleared application CellenkosCellenkos CK0802 IND Clearance
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United States — Food and Drug Administration approved label expansion ArgenxFDA Expands VYVGART,...
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United States — Food and Drug Administration granted clearance Datar Cancer GeneticsDatar Cancer Genetics US...
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United States — Food and Drug Administration approved drug Trastuzumab deruxtecanEnhertu FDA Approvals for...
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United States — United States Court of Appeals for the Third Circuit blocked federal rule United States — Food and Drug AdministrationCourt Blocks Mifepristone...
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United States — Food and Drug Administration sent warning letter ImmunityBioImmunityBio Faces Anktiva...
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United States — Food and Drug Administration issued Complete Response Letter Atara BiotherapeuticsAtara Biotherapeutics...
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Tracy Beth Høeg expected to leave United States — Food and Drug AdministrationFDA Drug Center Head Departs
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AstraZeneca received approval United States — Food and Drug AdministrationFDA Approves ENHERTU for...
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Daiichi Sankyo received approval United States — Food and Drug AdministrationFDA Approves ENHERTU for...
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United States — Food and Drug Administration issued warning letter ImmunityBioImmunityBio FDA Warning, Stock Drop
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United States — Food and Drug Administration issued Complete Response Letter Disc MedicineDisc Medicine FDA...
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United States — Food and Drug Administration issued Complete Response Letter Atara BiotherapeuticsAtara Biotherapeutics...
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United States — Food and Drug Administration issued Complete Response Letter Atara BiotherapeuticsAtara Biotherapeutics...
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United States — Food and Drug Administration consolidated data sourcesFDA Launches Elsa 4.0,...
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United States — Food and Drug Administration announced recall Fly By JingFly By Jing Noodles Peanut Recall
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Cellenkos announced clearance United States — Food and Drug AdministrationCellenkos CK0802 IND Clearance
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Kyle Diamantas to take over United States — Food and Drug AdministrationMarty Makary Resigns FDA...
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Tracy Beth Høeg expected to leave United States — Food and Drug AdministrationFDA Leadership Shake-up:...
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United States — Food and Drug Administration integrated platformsFDA Launches Elsa 4.0,...
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United States — Food and Drug Administration approved system Recor MedicalRecor Medical Highlights...
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United States — Food and Drug Administration lost employeesTrump plans to fire FDA...
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United States — Food and Drug Administration requested additional information EisaiLeqembi Iqlik PDUFA Date Extended
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United States — United States Court of Appeals for the Third Circuit blocked federal rule United States — Food and Drug AdministrationSupreme Court Restores...
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United States — Louisiana filed lawsuit United States — Food and Drug AdministrationCourt Blocks Mifepristone...
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Applied Therapeutics
regulated
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United States — Food and Drug Administration
Applied Therapeutics is a biopharmaceutical company strictly regulated by the FD
Marty Makary
ex-commissioner
↔
United States — Food and Drug Administration
Marty Makary served as the Commissioner of the Food and Drug Administration for
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