United States — Food and Drug Administration & United States
79 shared events · Importance 24 · Last updated May 17, 2026
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Regulatory
United States — Food and Drug Administration: 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.
United States: The United States' regulatory landscape for drugs and vaccines is affected by the leadership changes at the United States — Food and Drug Administration.
May 16, 2026 · 10 articles
Regulatory
United States — Food and Drug Administration: 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.
United States: The ruling significantly curtails access to Mifepristone nationwide and impacts the ongoing legal battles over abortion access in the United States.
May 01, 2026 · 78 articles
Regulatory
United States — Food and Drug Administration: 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.
United States: The United States is the nation where these regulatory discussions and initiatives regarding SSRIs are taking place, impacting its healthcare system and pharmaceutical market.
May 08, 2026 · 6 articles
Regulatory
United States — Food and Drug Administration: 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.
United States: The United States' health policy and regulatory landscape are being reshaped by the ongoing personnel changes and political influence within its government agencies, particularly concerning vaccine policies.
May 15, 2026 · 6 articles
Business
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.
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.
Apr 09, 2026 · 6 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration approved Trastuzumab deruxtecan for two new breast cancer indications, enabling its use in neoadjuvant and adjuvant settings.
United States: The United States — Food and Drug Administration approved Trastuzumab deruxtecan for new indications, impacting the healthcare market and patients within the United States.
May 15, 2026 · 9 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration approved the oral contraceptive 66 years ago, enabling its widespread use and subsequent societal impact.
United States: The United States experienced significant social and demographic changes due to the introduction and widespread use of the birth control pill.
May 12, 2026 · 7 articles
Domestic
United States — Food and Drug Administration: 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.
United States: The United States plays a critical role in confirming leadership positions within the United States — United States Department of Health and Human Services, with partisan majorities affecting the appointment process.
May 13, 2026 · 6 articles
Domestic
United States — Food and Drug Administration: 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.
United States: The United States will need to confirm a permanent replacement for the United States — Food and Drug Administration Commissioner, which could take up valuable floor time ahead of the midterms.
May 08, 2026 · 35 articles
International
United States — Food and Drug Administration: The United States — Food and Drug Administration is experiencing leadership changes with Dr. Marty Makary's resignation and Kyle Diamantas taking over as acting commissioner.
United States: The United States is involved in a war with Iran, which is causing rising inflation and impacting its economy. It is also engaged in trade discussions with China and has a significant defense budget.
May 13, 2026 · 6 articles
Domestic
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.
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.
Apr 01, 2026 · 14 articles
International
United States — Food and Drug Administration: Marty Makary is resigning as head of the United States — Food and Drug Administration after facing complaints from various groups and internal staff.
United States: The United States experienced a 3.8% inflation surge, fueled by rising gasoline prices due to the Iran war.
May 12, 2026 · 9 articles
Domestic
United States — Food and Drug Administration: The United States — Food and Drug Administration's regulations regarding mifepristone access were challenged, and the agency is conducting a safety review of the medication.
United States: The United States is the nation where this legal battle over abortion pill access is taking place, with implications for healthcare and legal frameworks across its states.
May 04, 2026 · 52 articles
International
United States — Food and Drug Administration: The United States — Food and Drug Administration experienced leadership shake-ups, with its top drug official, Dr. Tracy Beth Høeg, being fired and Commissioner Marty Makary resigning.
United States: The United States is engaged in a war with Iran and has dismissed Iran's ceasefire proposals. It also conducted a joint mission with Nigeria to kill a leader of the Islamic State group and is facing domestic economic challenges with rising inflation.
May 16, 2026 · 7 articles
International
United States — Food and Drug Administration: The United States — Food and Drug Administration is conducting a new review of mifepristone's safety, and a court panel is requiring in-person distribution of the pill.
United States: The United States, under Donald Trump's administration, is involved in negotiations with Iran, imposing tariffs on the European Union, and approving a new oil pipeline from Canada. It is also deploying AI technology in its military.
May 01, 2026 · 6 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration provided clarity on the reclassification pathway for OAY-related equipment, which is expected to create a larger commercial opportunity for Photocure in the U.S. market.
United States: Photocure expanded its blue-light cystoscopy use in the United States and anticipates a larger commercial opportunity due to FDA reclassification.
May 07, 2026 · 6 articles
International
United States — Food and Drug Administration: The United States — Food and Drug Administration is experiencing leadership changes with the resignation of Marty Makary, leading to uncertainty about the fate of various initiatives.
United States: The United States is engaged in a war with Iran, facing rising consumer prices due to energy costs and congressional scrutiny over the war's costs and strategy. Donald Trump is attempting to negotiate an end to the conflict.
May 12, 2026 · 49 articles
Tech
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.
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.
Nov 03, 2025 · 9 articles
Regulatory
United States — Food and Drug Administration: 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.
United States: The recalls occurred in the United States, affecting consumers and regulatory bodies within the country.
May 13, 2025 · 6 articles
Business
United States — Food and Drug Administration: The acquired Rockville facility has been inspected by the United States — Food and Drug Administration, indicating its compliance with regulatory standards.
United States: The acquisition strengthens Bora Pharmaceuticals' biologics CDMO platform in the United States, with the acquired facility located in Rockville, Maryland.
May 12, 2026 · 6 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration approved the Paradise uRDN system for sale in the United States in November 2023.
United States: The Paradise uRDN system received FDA approval in the United States in November 2023 and is commercially available for patients there.
May 15, 2026 · 7 articles
Domestic
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.
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.
Apr 08, 2026 · 15 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration granted Priority Review to BeOne Medicines' Next-Generation BCL-2 Inhibitor and sets manufacturing standards for BeOne Medicines' Suzhou facility.
United States: The United States hosts one of BeOne Medicines' production sites in New Jersey, serving as a North America biologics hub.
May 11, 2026 · 6 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration granted Priority Review to Eisai's supplemental Biologics License Application for a subcutaneous starting dose with Lecanemab Iqlik, with a PDUFA date set for August 24, 2026.
United States: The United States is one of the countries where Lecanemab is approved for intravenous maintenance dosing and where Lecanemab Iqlik is approved for subcutaneous dosing.
May 15, 2026 · 6 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
Domestic
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned in the context of its former vaccine chief, Peter Marks, who criticized the current health secretary's approach to vaccine safety.
Mar 11, 2025 · 24 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration does not regulate Melatonin as a drug in the United States, which means manufacturers are not subject to the same scrutiny as prescription medications.
Nov 03, 2025 · 6 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration classified a previous PepsiCo — Frito-Lay recall as Class I, indicating its role in overseeing food safety and product recalls.
Mar 26, 2025 · 7 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned as the regulatory body whose standards AquaSculpt's manufacturing facilities adhere to, ensuring product quality and safety.
Mar 20, 2025 · 7 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
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