United States — Food and Drug Administration & American Society of Clinical Oncology
11 shared events · Importance 4 · Last updated Jun 12, 2026
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Tech
United States — Food and Drug Administration: FDA granted Breakthrough Device Designation to SPOT-MAS 10, a non-approval milestone that facilitates regulatory review.
American Society of Clinical Oncology: ASCO highlighted the study in its press center and Science in Seconds, lending credibility to the technology.
Jul 06, 2026 · 6 articles
Tech
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.
American Society of Clinical Oncology: The American Society of Clinical Oncology meeting in Chicago was the venue where the significant findings of the daraxonrasib study were presented to the medical community.
May 29, 2026 · 74 articles
Tech
United States — Food and Drug Administration: The FDA will review the trial data for potential approval. The companies plan to file for approval, and the vaccine could be available as soon as 2027 if approved.
American Society of Clinical Oncology: ASCO's chief medical officer called the results a 'monumental leap forward,' and the organization hosted the Phase 2 data presentation.
Aug 19, 2026 · 108 articles
Regulatory
United States — Food and Drug Administration: The FDA accepted the NDA for review and will decide on approval by April 28, 2027, playing a critical regulatory role in the event.
American Society of Clinical Oncology: The RINGSIDE trial results were presented at the 2026 ASCO Annual Meeting, providing a platform for data dissemination.
Jul 08, 2026 · 6 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) has granted two Fast Track Designations to IBI363, indicating its potential to address unmet medical needs and expedite its development and review process.
American Society of Clinical Oncology: The American Society of Clinical Oncology (ASCO) Annual Meeting is the platform where the updated clinical data for IBI363 was presented, providing a significant forum for disseminating these important findings to the medical and scientific community.
May 21, 2026 · 9 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) granted Fast Track Designation to golidocitinib in February 2022, accelerating its development pathway in the US.
American Society of Clinical Oncology: The American Society of Clinical Oncology (ASCO) Annual Meeting served as the platform for Dizal Pharmaceutical to present its clinical trial results, providing a credible forum for dissemination.
May 31, 2026 · 6 articles
Business
United States — Food and Drug Administration: FDA received sNDA for first-line Zegfrovy and granted Breakthrough Therapy Designation.
American Society of Clinical Oncology: ASCO hosted presentation of WU-KONG28 trial results as a Late-Breaking Abstract.
Jul 14, 2026 · 8 articles
Business
United States — Food and Drug Administration: The FDA approved Celcuity's product REVTORPYK, which is mentioned in the announcement. The event does not involve new FDA actions, but the approval is part of the company's background.
American Society of Clinical Oncology: ASCO is mentioned as the venue where results from the VIKTORIA-1 trial were presented. The event does not involve new ASCO actions, but the presentation is part of the company's clinical development history.
Aug 06, 2026 · 6 articles
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