• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI SuperconnectorNEW
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • AI SuperconnectorNEW
  • Settings
  • RSS Feeds
PublishGo to AppAI Superconnector
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlertsPublish with Us
    Company
    AboutQuantisnow PlusContactJobsAI superconnector for talent & startupsNEWLLM Arena
    Legal
    Terms of usePrivacy policyCookie policy

    May 21, 2021 - FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

    5/21/21 12:50:51 PM ET
    $JNJ
    $GH
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Medical Specialities
    Health Care
    Get the next $JNJ alert in real time by email
    For Immediate Release:
    May 21, 2021

    Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

    The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant today.

    “Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” said Julia Beaver, M.D., chief of medical oncology in the FDA’s Oncology Center of Excellence and acting deputy director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “With today’s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.”

    Lung cancer is the most common cancer type and the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer accounting for 80% to 85% of all lung cancers, according to the American Cancer Society. Approximately 2% to 3% of patients with non-small cell lung cancer will have EGFR exon 20 insertion mutations, which are a group of mutations on a protein that causes rapid cell growth, and consequently, helps cancer spread. EGFR exon 20 insertion mutations are the third most common type of EGFR mutation.

    Researchers evaluated Rybrevant’s efficacy in a study of 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy. The main outcome measured was overall response rate (proportion of patients whose tumor is destroyed or reduced by a drug). In the trial population in which all patients received Rybrevant, the overall response rate was 40%. The median duration of response was 11.1 months, with 63% of patients having a duration of response of 6 months or more.

    The most common side effects of Rybrevant include rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting and changes in certain blood tests. Rybrevant should be withheld if patients develop symptoms of interstitial lung disease and permanently discontinued if interstitial lung disease is confirmed. Patients taking Rybrevant should limit sun exposure during and for two months after treatment. Rybrevant may cause problems with vision. Rybrevant can also cause fetal harm when administered to a pregnant woman; therefore, the pregnancy status of females of reproductive potential should be confirmed before treatment is started.

    Rybrevant received Priority Review and Breakthrough Therapy designation for this indication. Priority Review directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

    The FDA granted approval of Rybrevant to Janssen Pharmaceutical Companies of Johnson & Johnson.

    This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with the Brazilian Health Regulatory Agency and United Kingdom’s Medicines and Healthcare products Regulatory Agency. The application reviews are ongoing at the other regulatory agencies.

     

    ###

    Boilerplate

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


    Inquiries

    Media:
    Shannon P. Hatch
    202-510-1973
    Consumer:
    888-INFO-FDA

    Get the next $JNJ alert in real time by email

    Crush Q3 2025 with the Best AI Superconnector

    Stay ahead of the competition with Standout.work - your AI-powered talent-to-startup matching platform.

    AI-Powered Inbox
    Context-aware email replies
    Strategic Decision Support
    Get Started with Standout.work

    Recent Analyst Ratings for
    $JNJ
    $GH

    CompanyDatePrice TargetRatingAnalyst
    Johnson & Johnson
    $JNJ
    10/20/2025$203.00Neutral → Outperform
    Daiwa Securities
    Johnson & Johnson
    $JNJ
    10/3/2025$212.00Equal Weight → Overweight
    Wells Fargo
    Guardant Health Inc.
    $GH
    9/25/2025$75.00Peer Perform → Outperform
    Wolfe Research
    Johnson & Johnson
    $JNJ
    9/23/2025$206.00Neutral → Buy
    Guggenheim
    Guardant Health Inc.
    $GH
    9/22/2025$72.00Overweight
    Wells Fargo
    Johnson & Johnson
    $JNJ
    7/23/2025Hold → Buy
    Erste Group
    Johnson & Johnson
    $JNJ
    5/13/2025$153.00Outperform → Market Perform
    Leerink Partners
    Guardant Health Inc.
    $GH
    4/10/2025$55.00Outperform
    Mizuho
    More analyst ratings

    $JNJ
    $GH
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    View All

    Director Mignone Roberto converted options into 3,167 shares (SEC Form 4)

    4 - Guardant Health, Inc. (0001576280) (Issuer)

    10/22/25 7:07:55 PM ET
    $GH
    Medical Specialities
    Health Care

    Director Hidalgo Medina Manuel converted options into 232 shares, increasing direct ownership by 21% to 1,315 units (SEC Form 4)

    4 - Guardant Health, Inc. (0001576280) (Issuer)

    10/20/25 7:50:40 PM ET
    $GH
    Medical Specialities
    Health Care

    Director Tariq Musa sold $7,766 worth of shares (116 units at $66.95), decreasing direct ownership by 1% to 7,725 units (SEC Form 4)

    4 - Guardant Health, Inc. (0001576280) (Issuer)

    10/20/25 7:49:44 PM ET
    $GH
    Medical Specialities
    Health Care

    $JNJ
    $GH
    Press Releases

    Fastest customizable press release news feed in the world

    View All

    Johnson & Johnson to Participate in the 7th Annual Wolfe Research Healthcare Conference

    Johnson & Johnson (NYSE:JNJ) will present at the 7th Annual Wolfe Research Healthcare Conference on Monday, November 17th, 2025. Management will participate in a Fireside Chat at 10:40 a.m. Eastern Time. A live audio webcast of the presentation will be accessible through Johnson & Johnson's Investor Relations website at www.investor.jnj.com. An archived edition of the session will be available later that day. The audio webcast replay will be available approximately 48 hours after the webcast. View source version on businesswire.com: https://www.businesswire.com/news/home/20251022905443/en/ Media contact: [email protected] Investor contact: [email protected]

    10/22/25 4:36:00 PM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Subcutaneous amivantamab delivers promising 45 percent overall response rate with median duration of 7.2 months in recurrent or metastatic head and neck cancer

    Responses were rapid and durable, and tumor shrinkage was observed in 82 percent of patients New findings from this investigational study build on the strength of RYBREVANT® (amivantamab-vmjw) in non-small cell lung cancer and broadens its potential across additional solid tumors RARITAN, N.J., Oct. 19, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced promising new results from the Phase 1b/2 OrigAMI-4 study evaluating the efficacy and safety of subcutaneous (SC) amivantamab monotherapy in patients with human papillomavirus (HPV)-unrelated, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after disease progression on a checkpoint inhibitor and plat

    10/19/25 10:30:00 AM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care

    First Phase 3 study (MajesTEC-3) of an investigational combination to show benefit in PFS and OS in relapsed/refractory multiple myeloma as early as second line Independent Data Monitoring Committee (IDMC) recommended unblinding the study based on statistically significant results RARITAN, N.J., Oct. 16, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma therapies, today announced positive topline results from the investigational Phase 3 MajesTEC-3 study. The study evaluates the efficacy and safety of TECVAYLI® (teclistamab-cqyv) in com

    10/16/25 8:00:00 AM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $JNJ
    $GH
    Insider Purchases

    Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

    View All

    Director Weinberger Mark A bought $147,220 worth of shares (1,000 units at $147.22) (SEC Form 4)

    4 - JOHNSON & JOHNSON (0000200406) (Issuer)

    12/12/24 5:27:36 PM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Kalia Kumud bought $38,963 worth of shares (2,187 units at $17.82), increasing direct ownership by 21% to 12,722 units (SEC Form 4)

    4 - Guardant Health, Inc. (0001576280) (Issuer)

    3/19/24 5:29:06 PM ET
    $GH
    Medical Specialities
    Health Care

    $JNJ
    $GH
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    View All

    Johnson & Johnson upgraded by Daiwa Securities with a new price target

    Daiwa Securities upgraded Johnson & Johnson from Neutral to Outperform and set a new price target of $203.00

    10/20/25 8:00:27 AM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Johnson & Johnson upgraded by Wells Fargo with a new price target

    Wells Fargo upgraded Johnson & Johnson from Equal Weight to Overweight and set a new price target of $212.00

    10/3/25 8:30:20 AM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Guardant Health upgraded by Wolfe Research with a new price target

    Wolfe Research upgraded Guardant Health from Peer Perform to Outperform and set a new price target of $75.00

    9/25/25 8:22:52 AM ET
    $GH
    Medical Specialities
    Health Care

    $JNJ
    $GH
    SEC Filings

    View All

    SEC Form 10-Q filed by Johnson & Johnson

    10-Q - JOHNSON & JOHNSON (0000200406) (Filer)

    10/22/25 4:04:17 PM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form 144 filed by Guardant Health Inc.

    144 - Guardant Health, Inc. (0001576280) (Subject)

    10/17/25 4:00:32 PM ET
    $GH
    Medical Specialities
    Health Care

    Johnson & Johnson filed SEC Form 8-K: Results of Operations and Financial Condition, Other Events, Financial Statements and Exhibits

    8-K - JOHNSON & JOHNSON (0000200406) (Filer)

    10/14/25 7:22:58 AM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $JNJ
    $GH
    FDA approvals

    Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

    View All

    July 30, 2024 - FDA Roundup: July 30, 2024

    For Immediate Release: July 30, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA is announcing the fiscal year (FY) 2025 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party C

    7/30/24 3:38:18 PM ET
    $GH
    Medical Specialities
    Health Care

    July 21, 2023 - FDA Roundup: July 21, 2023

    For Immediate Release: July 21, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA Center for Tobacco Products (CTP) announced that the center will host a virtual listening session on Aug. 22, 2023. During this listening session, CTP is requesting feedback on the development of a new 5-year strategic plan for the center, includin

    7/21/23 4:02:23 PM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    May 5, 2022 - Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

    For Immediate Release: May 05, 2022 Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not

    5/5/22 4:51:11 PM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $JNJ
    $GH
    Leadership Updates

    Live Leadership Updates

    View All

    Vicarious Surgical Announces Appointment of Joseph Doherty as Chairman of The Board

    Vicarious Surgical Inc. (NYSE:RBOT, RBOT.WS)) (the "Company"), a next-generation robotics technology company seeking to improve lives by transforming robotic surgery, today announced the appointment of Joseph Doherty as Chairman of the Company's Board of Directors (the "Board"). Mr. Doherty has served as a member of the Board since June 2025. "Since joining Vicarious Surgical, I've had the opportunity to work closely with Joe and greatly value his perspective," said Stephen From, Chief Executive Officer. "As Chairman of the Board, he brings a wealth of experience and thoughtful leadership that will serve the Company well. I look forward to partnering with him and the Board as we advance o

    9/25/25 4:15:00 PM ET
    $JNJ
    $RBOT
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Industrial Specialties

    Alex M. Azar II Joins Guardant Health Board of Directors

    Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the appointment of Alex M. Azar II to its board of directors, effective immediately. As the 24th Secretary of the U.S. Department of Health and Human Services (HHS), Secretary Azar had oversight and management of agencies critical to all Americans' health care including the Centers for Medicare and Medicaid Services, the Food and Drug Administration, and the Center for Disease Control and Prevention. "We're honored to welcome Secretary Azar to Guardant's board," said Helmy Eltoukhy, chairman and co-CEO of Guardant Health. "Secretary Azar has served at the senior-most levels of government as well as th

    9/15/25 4:07:00 PM ET
    $GH
    Medical Specialities
    Health Care

    Johnson & Johnson Elects John Morikis, Retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, to its Board of Directors

    Johnson & Johnson (NYSE:JNJ) announced today that John Morikis, retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, has been elected to its Board of Directors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250908666514/en/John Morikis headshot "We are pleased to welcome John to our Company's Board of Directors," said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. "He is a proven leader of a large multinational organization who possesses a strong understanding of global markets and complex supply chains. His unique perspective and ability to harness technology to driv

    9/8/25 6:17:00 PM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $JNJ
    $GH
    Financials

    Live finance-specific insights

    View All

    Johnson & Johnson Announces Quarterly Dividend for Fourth Quarter 2025

    Johnson & Johnson (NYSE:JNJ) today announced that its Board of Directors has declared a cash dividend for the fourth quarter of 2025 of $1.30 per share on the company's common stock. The dividend is payable on December 9, 2025 to shareholders of record at the close of business on November 25, 2025. The ex-dividend date is November 25, 2025. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquel

    10/14/25 6:30:00 AM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Johnson & Johnson Announces Intent to Separate Its Orthopaedics Business

    Strengthens focus of Johnson & Johnson as an innovation powerhouse and accelerates the portfolio shift of its MedTech Segment to higher-growth and higher-margin markets Standalone orthopaedics business would operate as DePuy Synthes and be the largest, most comprehensive orthopaedics-focused company in the world Namal Nawana appointed to serve as Worldwide President of DePuy Synthes Johnson & Johnson (the "Company") (NYSE:JNJ) today announced the Company's intent to separate its Orthopaedics business to enhance the strategic and operational focus of each company and drive value for stakeholders. The intended separation would further strengthen the focus of Johnson & Johnson as an in

    10/14/25 6:21:00 AM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Johnson & Johnson Reports Q3 2025 Results; Raises 2025 Sales Outlook

    2025 Third-Quarter reported sales growth of 6.8% to $24.0 Billion with operational growth of 5.4%* and adjusted operational growth of 4.4%* 2025 Third-Quarter reflects earnings per share (EPS) of $2.12 and adjusted EPS of $2.80 Significant innovation including approvals of INLEXZO for high-risk non-muscle invasive bladder cancer and TREMFYA subcutaneous in ulcerative colitis, submission of icotrokinra for plaque psoriasis, landmark data for RYBREVANT plus LAZCLUZE overall survival in non-small cell lung cancer, and DanGer Shock long-term survival benefit of Impella Heart Pump Company increases full year estimated reported sales5 guidance to $93.7B or 5.7% at the midpoint; reaffirm

    10/14/25 6:20:00 AM ET
    $JNJ
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $JNJ
    $GH
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    View All

    SEC Form SC 13G filed by Guardant Health Inc.

    SC 13G - Guardant Health, Inc. (0001576280) (Subject)

    11/13/24 7:34:17 PM ET
    $GH
    Medical Specialities
    Health Care

    SEC Form SC 13G filed by Guardant Health Inc.

    SC 13G - Guardant Health, Inc. (0001576280) (Subject)

    11/8/24 10:46:38 AM ET
    $GH
    Medical Specialities
    Health Care

    Amendment: SEC Form SC 13G/A filed by Guardant Health Inc.

    SC 13G/A - Guardant Health, Inc. (0001576280) (Subject)

    7/5/24 10:32:48 AM ET
    $GH
    Medical Specialities
    Health Care