United States — Food and Drug Administration & Johnson & Johnson
15 shared events · Importance 6 · Last updated Jul 29, 2026
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Regulatory
United States — Food and Drug Administration: The United States — Food and Drug Administration approved the supplemental Biologics License Application for Guselkumab, allowing for the inclusion of new evidence in its label.
Johnson & Johnson: As the developer and manufacturer of Guselkumab, Johnson & Johnson benefits from the expanded FDA approval, which enhances the drug's market position and potential sales.
May 28, 2026 · 6 articles
Regulatory
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.
Johnson & Johnson: J&J received FDA authorization for its OTTAVA robotic system, marking its entry into the US soft-tissue robotic surgery market. This approval is a key milestone for its medtech business and positions it to compete with Intuitive Surgical and Medtronic.
Jul 22, 2026 · 20 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration>>>'s prior approval of 4-Aminopyridine>>> for other uses is crucial, as it could accelerate the new gel's path to clinical trials and market approval.
Johnson & Johnson: Johnson & Johnson>>> is an Assistant Professor at the Terasaki Institute for Biomedical Innovation>>> and a key researcher in the development of the 4-AP gel. His involvement highlights his expertise and contributes to his professional reputation.
Jun 04, 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.
Johnson & Johnson: Johnson & Johnson 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 United States — Food and Drug Administration is the regulatory body to which CereVasc will submit a Premarket Approval (PMA) for its eShunt System, a critical step for commercialization in the US.
Johnson & Johnson: Johnson & Johnson Innovation - JJDC, Inc., Johnson & Johnson's corporate venture capital arm, participated in the Series C financing, indicating its strategic interest in neurological disease treatments and potential future collaborations or acquisitions.
Jun 04, 2026 · 6 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration encourages the adoption of advanced manufacturing technologies and continuous production models, reinforcing the shift from reactive to proactive compliance strategies in the pharmaceutical industry.
Johnson & Johnson: Johnson & Johnson has invested in AI-powered platforms to enhance decision-making and streamline development processes, reflecting the industry's adoption of intelligent manufacturing.
Apr 07, 2026 · 8 articles
Business
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>>>.
Johnson & Johnson: Johnson & Johnson>>> owns the trademarks for Simponi and Simponi Aria, the reference products for Alvogen>>>'s AVT05 biosimilar. The potential market entry of AVT05 could introduce competition to Johnson & Johnson>>>'s products.
Jun 04, 2026 · 10 articles
Regulatory
United States — Food and Drug Administration: The FDA conducted and closed the inspection, classifying the site as VAI, and is reviewing Alvogen's BLAs; its actions directly affect Alvogen's regulatory progress.
Johnson & Johnson: Holder of Simponi trademark; Alvogen's biosimilar AVT05 targets Simponi, but no direct impact from this event.
Jul 29, 2026 · 7 articles
Business
United States — Food and Drug Administration: The FDA granted Breakthrough Therapy Designation to BPL-003 and announced regulatory actions to support psychedelic drug development, facilitating the path to market.
Johnson & Johnson: Johnson & Johnson faces new competition in the treatment-resistant depression market as Lilly's acquisition of Atai Life Sciences positions BPL-003 as a potential rival to J&J's Spravato.
Jul 16, 2026 · 25 articles
Regulatory
United States — Food and Drug Administration: Trump administration announced FDA would add warnings to Tylenol; not a party to lawsuit.
Johnson & Johnson: Former parent of Kenvue; spun off in 2023, not directly involved but legacy exposure.
Jul 13, 2026 · 23 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration advised doctors to consider minimizing acetaminophen's use in pregnancy, amid inconclusive evidence about a link to autism.
Johnson & Johnson: Johnson & Johnson spun off Kenvue two years prior to this acquisition, aiming to make its pharmaceutical and medical device divisions more nimble.
Nov 03, 2025 · 10 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration is currently reviewing the New Drug Application for rusfertide.
Johnson & Johnson: Johnson & Johnson, through its subsidiary Johnson & Johnson — Janssen Pharmaceuticals, Inc., is a licensee of ICOTYDE, a drug jointly discovered with AnBogen Therapeutics.
May 28, 2026 · 6 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration is currently reviewing the New Drug Application for rusfertide for the treatment of polycythemia vera.
Johnson & Johnson: Johnson & Johnson is the parent company of Johnson & Johnson — Janssen Pharmaceuticals, which is involved in the development and commercialization of ICOTYDE.
Jun 16, 2026 · 6 articles
Business
United States — Food and Drug Administration: The FDA is reviewing the NDA for rusfertide. This event does not affect the FDA.
Johnson & Johnson: Johnson & Johnson is the licensee of ICOTYDE, which is launched and in Phase 3 for additional indications. This event does not directly affect J&J.
Aug 04, 2026 · 9 articles
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