United States — Food and Drug Administration & Roche
10 shared events · Importance 4 · Last updated Aug 24, 2026
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Regulatory
United States — Food and Drug Administration: The FDA granted clearance to the Elecsys pTau217 blood test, a regulatory action that enables U.S. marketing and use of the test.
Roche: Roche developed the test and received FDA clearance, expanding its Alzheimer's diagnostic portfolio and potentially increasing revenue from test sales and analyzer usage.
Aug 24, 2026 · 7 articles
Regulatory
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> granted Priority Review for Roche>>>'s Atezolizumab, indicating a potential new treatment option for colon cancer patients.
Roche: Roche's supplemental Biologics License Application for Atezolizumab has been accepted by the United States — Food and Drug Administration>>> for Priority Review, potentially leading to a new standard of care for stage III colon cancer and boosting its market position.
Jun 11, 2026 · 6 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted F. Hoffmann-La Roche — Genentech>>>'s New Drug Application for giredestrant under Priority Review, setting a decision date for approval by November 30, 2026.
Roche: As the parent company of F. Hoffmann-La Roche — Genentech>>>, Roche>>> benefits from the positive developments regarding giredestrant's regulatory progress and its potential market impact.
Jun 02, 2026 · 6 articles
Business
United States — Food and Drug Administration: The FDA is investigating the outbreak and is referenced, but the new tests are research-use-only and not subject to FDA approval.
Roche: Roche is the main actor, launching new PCR tests to expand its cyclospora portfolio, reinforcing its position in infectious disease diagnostics and potentially boosting sales.
Aug 06, 2026 · 6 articles
Business
United States — Food and Drug Administration: The US FDA provides supportive regulatory frameworks that facilitate product approvals and market growth in North America.
Roche: Roche is a key player in the antibody therapeutics market, benefiting from the projected market growth.
Jul 28, 2026 · 6 articles
Business
United States — Food and Drug Administration: The FDA granted IND clearance for HM17321 in November 2025, enabling the Phase 1 trial. Its regulatory role is crucial for the drug's development.
Roche: As the parent of F. Hoffmann-La Roche — Genentech, Roche strengthens its cardiometabolic portfolio, aligning with its strategy to address obesity and related conditions.
Jul 20, 2026 · 7 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.
Roche: Roche is testing a similar personalized cancer vaccine, and the positive results could boost its own development efforts.
Aug 19, 2026 · 108 articles
Regulatory
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.
Roche: Roche, parent of F. Hoffmann-La Roche — Genentech, stands to benefit from expanded use of Tecentriq in MIBC, potentially increasing drug sales.
Aug 05, 2026 · 7 articles
Regulatory
United States — Food and Drug Administration: The FDA granted approval for the phase II trial, acting as the regulatory authority enabling the clinical development of ziresovir in the U.S.
Roche: Roche is a strategic partner of ArkBio, and the advancement of ziresovir could strengthen their collaboration and potential commercial interests.
Jul 20, 2026 · 6 articles
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United States — Food and Drug Administration cleared blood test RocheFDA clears Roche Lilly...
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