• 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 & startupsNEW
    Legal
    Terms of usePrivacy policyCookie policy

    August 22, 2024 - FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

    8/22/24 1:28:17 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $PFE alert in real time by email
    For Immediate Release:
    August 22, 2024

    Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.

    In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible.

    “Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

    The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age.

    What You Need to Know

    • Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine.
    • Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
    • Individuals 5 years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine.
    • Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is administered at least 2 months since the last dose of any COVID-19 vaccine.
    • Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine fact sheets.

    Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines and as described in the respective prescribing information or fact sheets. The updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants. Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines.

    For today’s approvals and authorizations of the mRNA COVID-19 vaccines, the FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines. The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks.

    On an ongoing basis, the FDA will review any additional COVID-19 vaccine applications submitted to the agency and take appropriate regulatory action.

    The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc.

    The approval of Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to ModernaTX Inc. and the EUA amendment for the Moderna COVID-19 Vaccine (2024-2025 Formula) was issued to ModernaTX Inc.

    Related Information

    Related Information
    • Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula)
    • Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula)
    • Moderna COVID-19 Vaccine (2024-2025 Formula)
    • Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)
    • FDA Resources for the Fall Respiratory Illness Season
    • Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024
    • June 5, 2024, Meeting of the Vaccines and Related Biological Products Advisory Committee

    ###

    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, radiation-emitting electronic products, and for regulating tobacco products.


    Inquiries

    Media:
    FDA Office of Media Affairs
    301-796-4540
    Consumer:
    888-INFO-FDA

    Get the next $PFE 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
    $PFE

    DatePrice TargetRatingAnalyst
    4/22/2025$24.00Neutral
    Cantor Fitzgerald
    12/10/2024$29.00Neutral
    BofA Securities
    11/15/2024$25.00Underperform
    Wolfe Research
    10/25/2024$30.00Neutral
    Citigroup
    10/17/2024$32.00Mkt Perform
    Bernstein
    8/7/2024Neutral → Outperform
    Daiwa Securities
    3/22/2024Buy → Hold
    Argus
    2/23/2024$36.00Buy
    Guggenheim
    More analyst ratings

    $PFE
    Press Releases

    Fastest customizable press release news feed in the world

    View All

    Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients

    Voluntary agreement meets the President's four requests while also protecting the U.S. ecosystem responsible for America's leadership in delivering medical breakthroughs Agreement provides certainty from tariffs and clarity on pricing framework that furthers Pfizer's ability to expand investment in U.S.-based innovation and return manufacturing to the U.S. Pfizer to fully focus on delivering the next generation of cures, especially in cancer, obesity, vaccines, and inflammation and immunology Pfizer CEO Albert Bourla joins President Donald J. Trump and members of his Administration in White House event today Pfizer Inc. (NYSE:PFE) today announced a historic agreement with the T

    9/30/25 12:45:00 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Hearing Against Pfizer Set For 29 September In Contraceptive 'Depo-Provera' Multidistrict Litigation Overseen By Levin Papantonio

    The number of lawsuits filed has tripled to over 1300 since May New US peer-reviewed study adds to body of research confirming link between use of Depo-Provera and increased risk of brain tumours Global pharmaceutical company Pfizer Inc. (NYSE: PFE), manufacturer of contraceptive injection Depo-Provera (DMPA), is facing a multidistrict litigation (MDL No. 3140) in the USA being brought on behalf of women who developed an intracranial meningioma, a type of brain tumour after using Pfizer's Depo-Provera. This litigation followed a study by EPI-PHARE (Roland et al.) published in March 2024 in the British Medical Journal, which found that women who had used the Pfizer contraceptive inje

    9/25/25 3:37:00 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025

    More than 45 abstracts, including five late-breaking presentations and recognition in Presidential Symposium, showcase impact of approved medicines and potential of next-generation pipeline Pfizer Inc. (NYSE: PFE) will highlight data across its extensive Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany. Data from more than 45 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 11 oral/mini oral presentations and five late-breaking sessions, will be presented across Pfizer's core scientific modalities and key tumor areas. "At ESMO, Pfizer is demonstrating how earlier in

    9/25/25 6:45:00 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    SEC Filings

    View All

    SEC Form 13F-HR filed by Pfizer Inc.

    13F-HR - PFIZER INC (0000078003) (Filer)

    8/11/25 5:08:12 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form 10-Q filed by Pfizer Inc.

    10-Q - PFIZER INC (0000078003) (Filer)

    8/5/25 7:16:27 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Pfizer Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

    8-K - PFIZER INC (0000078003) (Filer)

    8/5/25 7:08:22 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    Insider Purchases

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

    View All

    Director Blaylock Ronald E bought $499,072 worth of shares (19,457 units at $25.65), increasing direct ownership by 236% to 27,707 units (SEC Form 4)

    4 - PFIZER INC (0000078003) (Issuer)

    2/14/25 5:16:36 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Director Gottlieb Scott bought $28,240 worth of shares (1,000 units at $28.24), increasing direct ownership by 11% to 10,000 units (SEC Form 4)

    4 - PFIZER INC (0000078003) (Issuer)

    10/31/24 4:06:54 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Gottlieb Scott bought $79,401 worth of shares (3,000 units at $26.47), increasing direct ownership by 50% to 9,000 units (SEC Form 4)

    4 - PFIZER INC (0000078003) (Issuer)

    12/19/23 9:31:01 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    FDA approvals

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

    View All

    October 25, 2024 - FDA Roundup: October 25, 2024

    For Immediate Release: October 25, 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 updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to deter

    10/25/24 2:48:21 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    FDA Approval for HYMPAVZI issued to PFIZER INC

    Submission status for PFIZER INC's drug HYMPAVZI (ORIG-1) with active ingredient MARSTACIMAB-HNCQ has changed to 'Approval' on 10/11/2024. Application Category: BLA, Application Number: 761369, Application Classification:

    10/15/24 2:57:27 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    October 11, 2024 - FDA Approves New Treatment for Hemophilia A or B

    For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies). “Today’s approval of Hympavzi pro

    10/11/24 2:12:15 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    Leadership Updates

    Live Leadership Updates

    View All

    Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients

    Voluntary agreement meets the President's four requests while also protecting the U.S. ecosystem responsible for America's leadership in delivering medical breakthroughs Agreement provides certainty from tariffs and clarity on pricing framework that furthers Pfizer's ability to expand investment in U.S.-based innovation and return manufacturing to the U.S. Pfizer to fully focus on delivering the next generation of cures, especially in cancer, obesity, vaccines, and inflammation and immunology Pfizer CEO Albert Bourla joins President Donald J. Trump and members of his Administration in White House event today Pfizer Inc. (NYSE:PFE) today announced a historic agreement with the T

    9/30/25 12:45:00 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Dexcom Appoints Jon Coleman as Chief Commercial Officer

    DexCom, Inc. (NASDAQ:DXCM), the global leader in glucose biosensing, today announced the appointment of Jon Coleman as chief commercial officer. In this role, Mr. Coleman will assume responsibility for Dexcom's global commercial organization, including global sales, marketing and customer experience. Mr. Coleman joins Dexcom with more than 30 years of global commercial leadership experience across multiple healthcare segments and channels. Mr. Coleman served as an executive officer of Masimo Corporation (NASDAQ:MASI), where he held roles of increasing responsibility across his fifteen-year tenure. This included serving as president of Masimo's commercial teams where he oversaw the consolid

    3/25/25 4:05:00 PM ET
    $DXCM
    $MASI
    $PFE
    Medical/Dental Instruments
    Health Care
    Biotechnology: Electromedical & Electrotherapeutic Apparatus
    Biotechnology: Pharmaceutical Preparations

    FoRx Therapeutics Appoints Chief Medical Officer and Provides an Update on Its Lead Development Candidate

    Industry veteran in clinical development of oncology therapeutics, Dr. Jens Wurthner, PhD, joins as Chief Medical Officer Lead development candidate, FORX-428, a PARG inhibitor for solid tumors, maintains progress toward IND submission by mid-2025 FoRx Therapeutics AG, a Swiss-based company committed to discovering and developing innovative drugs targeting cancer-relevant DDR (DNA Damage Response) pathways, today announced that it has appointed Jens Würthner, MD PhD, as Chief Medical Officer. He is further strengthening FoRx Therapeutics' existing management team with CEO Tarig Bashir, CSO Frank Zenke, and Head of Chemistry Ulrich Lücking. Jens Würthner has 20+ years of clinical devel

    2/26/25 9:00:00 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    Insider Trading

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

    View All

    SEC Form 4 filed by Director Taraporevala Cyrus

    4 - PFIZER INC (0000078003) (Issuer)

    10/2/25 4:56:13 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form 4 filed by Director Smith James C

    4 - PFIZER INC (0000078003) (Issuer)

    10/2/25 4:56:12 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form 4 filed by Director Quincey James

    4 - PFIZER INC (0000078003) (Issuer)

    10/2/25 4:55:10 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    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

    Cantor Fitzgerald initiated coverage on Pfizer with a new price target

    Cantor Fitzgerald initiated coverage of Pfizer with a rating of Neutral and set a new price target of $24.00

    4/22/25 8:03:45 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    BofA Securities resumed coverage on Pfizer with a new price target

    BofA Securities resumed coverage of Pfizer with a rating of Neutral and set a new price target of $29.00

    12/10/24 8:32:32 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Wolfe Research initiated coverage on Pfizer with a new price target

    Wolfe Research initiated coverage of Pfizer with a rating of Underperform and set a new price target of $25.00

    11/15/24 8:17:04 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    View All

    SEC Form SC 13G/A filed by Pfizer Inc. (Amendment)

    SC 13G/A - PFIZER INC (0000078003) (Subject)

    2/9/23 11:30:22 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form SC 13D filed by Pfizer Inc.

    SC 13D - PFIZER INC (0000078003) (Filed by)

    7/27/22 4:42:06 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form SC 13G/A filed by Pfizer Inc. (Amendment)

    SC 13G/A - PFIZER INC (0000078003) (Subject)

    2/10/22 8:32:46 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    Financials

    Live finance-specific insights

    View All

    Pfizer Invites Public to View and Listen to Webcast of November 4 Conference Call with Analysts

    Pfizer Inc. (NYSE:PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10:00 a.m. EST on Tuesday, November 4, 2025. The purpose of the call is to provide an update on Pfizer's results, as reflected in the company's Third Quarter 2025 Performance Report, to be issued that morning. To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors. Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance of the conference call. You can also listen to the confer

    9/23/25 10:00:00 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio

    Proposed acquisition to add four highly differentiated clinical-stage incretin and amylin programs to Pfizer's pipeline Transaction valued at $47.50 per Metsera share in cash upon closing, for an initial enterprise value of $4.9 billion with a CVR of up to $22.50 per share in additional payments Pfizer to host a public webcast at 8 am EDT today Pfizer Inc. (NYSE:PFE) and Metsera, Inc. (NASDAQ:MTSR) today announced the companies have entered into a definitive agreement under which Pfizer will acquire Metsera, a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and cardiometabolic diseases. The acquisition brings deep expertise and a

    9/22/25 6:45:00 AM ET
    $MTSR
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Pfizer Reports Strong Second-Quarter 2025 Results And Raises 2025 EPS Guidance

    Strengthened Commercial Execution Driving Topline Growth Continued Progress Across R&D Pipeline Expanded Programs On Track to Deliver Net Cost Savings Targets Pfizer Inc. (NYSE:PFE) reported financial results for the second quarter of 2025 and reaffirmed its 2025 Revenue guidance while raising guidance(1) for Adjusted(2) diluted EPS. EXECUTIVE COMMENTARY Dr. Albert Bourla, Chairman and CEO of Pfizer: "Pfizer had another strong quarter of focused execution and we're pleased with our progress in advancing our R&D pipeline, driving our commercial performance and expanding our margins. We continue to strengthen our company for the future and we're confident in our ability to cre

    8/5/25 6:45:00 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care