Japan & United States — Food and Drug Administration
32 shared events · Importance 7 · Last updated Aug 24, 2026
Live sentiment trends, interaction importance charts, and action volume tracking available on the
Ergen Dashboard
Regulatory
Japan: Japan is the target market, with over 34,000 bladder cancer cases annually. Approval would provide Japanese patients access to a novel MRD-guided therapy approach.
United States — Food and Drug Administration: The FDA previously approved Signatera as a companion diagnostic for adjuvant Tecentriq, providing a regulatory precedent that supports the Japan submission.
Aug 05, 2026 · 7 articles
Regulatory
Japan: Japan is a market where Phase 3 trials are underway, potentially leading to a future regulatory submission.
United States — Food and Drug Administration: The FDA is reviewing the U.S. NDA for NCX 470, with approval expected in summer 2027. Its decision is critical for the drug's launch in the U.S.
Aug 10, 2026 · 6 articles
Business
Japan: AVT05, AVT06, and AVT03 have already been approved in Japan>>>, indicating their global market presence.
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
Japan: Regulators in Japan are considering bepirovirsen, which could expand the drug's market reach and provide a new treatment option for patients in the country.
United States — Food and Drug Administration: The United States — Food and Drug Administration is currently reviewing bepirovirsen for fast-track approval, and its decision in October will be crucial for the drug's market entry in the United States.
May 28, 2026 · 8 articles
Business
Japan: Japan is a country where Dyne Therapeutics is pursuing approval pathways for zeleciment basivarsen, as evidenced by the Orphan Drug designation from the Bangladesh — Ministry of Health and Family Welfare.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is the regulatory body responsible for granting Accelerated Approval and Priority Review for zeleciment basivarsen, which is crucial for its potential U.S. launch. The FDA has already granted Breakthrough Therapy, Orphan Drug, and Fast Track designations to zeleciment basivarsen.
Jun 03, 2026 · 6 articles
Business
Japan: Regulatory review ongoing; new drug application submitted in November 2025.
United States — Food and Drug Administration: Approved Leqembi Iqlik on July 13, enabling the US launch.
Aug 24, 2026 · 6 articles
Regulatory
Japan: Japan is identified as a key market for J&J's planned global expansion of the OTTAVA system.
United States — Food and Drug Administration: The FDA granted De Novo marketing authorization for J&J's OTTAVA system, clearing it for multiple general surgery procedures. This regulatory action enables J&J's commercial launch in the US.
Jul 22, 2026 · 20 articles
Regulatory
Japan: Japan is Nipro's home country and one of the regions where ELISIO-HX has prior clinical experience.
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
International
Japan: The Japanese market is trading sharply lower, reflecting the negative sentiment from Wall Street and concerns over the Middle East conflict's impact on global trade and energy supplies.
United States — Food and Drug Administration: The United States — Food and Drug Administration is the regulatory body that Revolution Medicines will seek approval from for its experimental pancreatic cancer drug, daraxonrasib.
May 18, 2026 · 316 articles
Business
Japan: Orphan drug designation for asedebart, facilitating development.
United States — Food and Drug Administration: Granted Fast Track designation to Lundbeck's Lu AH69593, supporting development of a potential new treatment.
Jul 20, 2026 · 7 articles
Domestic
Japan: Japan's experience with separate vaccines was cited as an example, but the country is not directly affected by the U.S. 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
Regulatory
Japan: PMX is approved for therapeutic use in Japan, demonstrating its established presence in international markets.
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
Business
Japan: Venglustat has orphan designation in Japan, suggesting future regulatory filings and market potential.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted priority review to Sanofi's venglustat, indicating its potential to address an unmet medical need for type 3 Gaucher disease.
May 28, 2026 · 6 articles
Tech
Japan: The BD BACTEC FXI Culture System is available in Japan after being licensed by the Japan — Pharmaceuticals and Medical Devices Agency.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted 510(k) clearance to the BD BACTEC FXI Culture System, allowing its commercialization in the U.S. market.
Jun 03, 2026 · 8 articles
Regulatory
Japan: QRX003 has Orphan Drug Designation in Japan for Netherton Syndrome, but Japan is not directly involved in this event.
United States — Food and Drug Administration: The FDA cleared the IND application for QRX003, expressing no safety concerns. This regulatory action allows Quoin to proceed with clinical development.
Jul 09, 2026 · 7 articles
Business
Japan: Japan is a key market for Nxera, with increasing revenues from PIVLAZ and QUVIVIQ. The company's commercial business in Japan continues to grow.
United States — Food and Drug Administration: The Taiwan FDA granted marketing approval for QUVIVIQ, a regulatory milestone that enables commercialization in Taiwan.
Aug 07, 2026 · 6 articles
Business
Japan: The acquired manufacturing platform supplies into multiple global markets including Japan, indicating its international reach and regulatory compliance with Japanese standards.
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
Business
Japan: Japan is a trial site and granted Orphan Drug Designation for YA-101.
United States — Food and Drug Administration: The FDA granted Fast Track and Orphan Drug Designations to YA-101, facilitating its development.
Jul 28, 2026 · 6 articles
Business
Japan: Japan's PMDA accreditation is among the regulatory approvals held by the company, supporting its market access.
United States — Food and Drug Administration: The USFDA accreditation is a key regulatory approval for the company, enabling access to the US market.
Aug 03, 2026 · 6 articles
Business
Japan: Market where RECELL is PMDA-approved; no direct impact from this event.
United States — Food and Drug Administration: Regulator that approved RECELL; mentioned as part of company background, no new regulatory action.
Aug 09, 2026 · 6 articles
Regulatory
Japan: Japan is mentioned as a country where Carl Zeiss Meditec has employees, but it is not directly affected by this event.
United States — Food and Drug Administration: The FDA granted 510(k) clearance for ZEISS CLINIC 360, a regulatory action that enables the product's commercial launch in the U.S. This clearance is a routine but essential step for medical device software.
Aug 19, 2026 · 6 articles
Business
Japan: Healome has patents granted in Japan.
United States — Food and Drug Administration: Healome plans to engage with the FDA for regulatory approval.
Jul 07, 2026 · 6 articles
Tech
Japan: Regulatory submissions for oveporexton are under review in Japan, which could open up a significant market for Takeda Pharmaceutical Company if approved.
Jun 15, 2026 · 6 articles
Business
Japan: Japan is where the NCX 470 Phase 3 clinical program was initiated in summer 2025.
Jun 18, 2026 · 7 articles
+ 2 more events
View on Dashboard
ERGEN INTELLIGENCE
Explore this relationship live
Track how Japan and United States — Food and Drug Administration interact across events, view sentiment trends, and discover connected entities.
Open Dashboard