Nuvaxovid™ is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season GAITHERSBURG, Md., Aug. 27, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration has approved the Nuvaxovid™ 2025-2026 Formula for the prevention of COVID-19 in adults 65 years and older or individuals 12 years through 64 years of age with at least one underlying condition that... Read more
The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains1 Shipping of the LP.8.1-adapted vaccine will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals, and clinics across the country NEW YORK & MAINZ, Germany / Aug 27, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX,... Read more
CAMBRIDGE, MA / ACCESS Newswire / August 27, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition... Read more
All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone CAMBRIDGE, MA / ACCESS Newswire / August 22, 2025 / Moderna announced today that Health Canada has authorized its updated COVID-19 mRNA vaccine, Spikevax®, targeting the SARS-CoV-2 LP.8.1 variant, for individuals aged six months and older. Moderna is on track to deliver the updated vaccine in time for the 2025-2026 vaccination season. All Spikevax pre-filled syringe (PFS)... Read more
Approximately one in five American adults who had COVID-19 still experience symptoms of long COVID, a serious illness that can result in chronic conditions and disability1.2 Long COVID remains a significant public health challenge with no currently available established treatments Study explores ANKTIVA’s therapeutic potential as an IL-15 agonist in boosting NK cell responses against viral infections CULVER CITY, Calif. / Aug 19, 2025 / Business Wire / ImmunityBio,... Read more
LP.8.1 variant adapted COVID-19 vaccine COMIRNATY is now authorized in Canada for individuals 6 months of age and older. It is expected to be available in Canada in the coming weeks. KIRKLAND, QC, Aug. 18, 2025 /CNW/ - Pfizer Canada ULC and BioNTech SE (Nasdaq: BNTX) "BioNTech" announced today that Health Canada has authorized the LP.8.1 variant adapted COMIRNATY® COVID-19 vaccine for individuals aged 6 months and older. The updated COMIRNATY® vaccine... Read more
New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA® (pemivibart) against XFG Centers for Disease Control data and wastewater surveillance data indicate XFG variant appears to be driving a growing wave of COVID-19 in America VYD2311 in vitro neutralization data demonstrate similarly consistent and highly potent results against XFG Similar new, positive in vitro neutralization data for pemivibart and VYD2311 against other... Read more
Non-inferiority trial to assess safety and efficacy, including rates of disease rebound and incidence of Long COVID development of ratutrelvir, a ritonavir-free treatment, compared to PAXLOVID® Separate single-arm trial will assess safety and efficacy in PAXLOVID®-ineligible subjects, who represent a significant vulnerable population with few available treatment options Top-line data from both trials expected by year-end 2025 NEWTOWN, Pa., Aug. 18, 2025 (GLOBE... Read more
CAMBRIDGE, MA / ACCESS Newswire / August 1, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the UK Court of Appeal has upheld the validity of Moderna's EP'949 patent. This decision affirms the High Court's initial ruling from July 2024 that the EP'949 patent is valid and infringed by Pfizer/BioNTech's COVID-19 vaccine, Comirnaty®, which was subsequently appealed by Pfizer/BioNTech. With this ruling, the UK becomes the first jurisdiction globally to issue a se... Read more
CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for the updated formulation of the COVID-19 vaccine Spikevax®, targeting the SARS-CoV-2 variant LP.8.1, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. This marketing authorization follows the Positive Opinion from the European Medicines Agency's (EMA)... Read more
New CLIA-Waived Test Delivers Digital Results to Support Timely Clinical Decision-Making FRANKLIN LAKES, N.J., July 30, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic individuals in about 15 minutes... Read more
Data indicate that the LP.8.1-adapted COVID-19 vaccine confers improved immune response against currently dominant and emerging sublineages – including the XFG and NB.1.8.1 variants1 – compared to 2024-2025 COVID-19 vaccine formulations Upon authorization by the European Commission (EC), the LP.8.1-adapted COVID-19 vaccine will be available for individuals 6 months of age and older To date, over a billion adults and children around the world have received the Pfi... Read more
Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision CAMBRIDGE, MA / ACCESS Newswire / July 25, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of the COVID-19 vaccine Spikevax®,... Read more
WALTHAM, Mass., July 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced the addition of Akiko Iwasaki, Ph.D., Professor of Immunobiology at Yale School of Medicine, to the SPEAR (Spike Protein Elimination and Recovery) Study Group. The SPEAR Study Group was launched earlier this month to focus on the biology and clinical disease or injury associated with persistent presence of spike antigen from SARS-CoV-2 virus or COVID-19 vaccines. Dr. Iwasaki... Read more
Attractive safety profile demonstrated across all dosing cohorts and routes of administration (IV, SC, and IM); all reported adverse events (AEs) deemed unrelated or classified as mild to moderate and largely related to injection site and infusion reactions with no serious or severe adverse events observed Following a single dose, serum concentrations of VYD2311 remained high at six months with an observed half-life of the IM dose route having the longest duration at... Read more
Both vaccine candidates induced robust immune responses across all antigens tested No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials Novavax continues to pursue partnering opportunities to advance further development of these programs GAITHERSBURG, Md., June 11, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC)... Read more
mNEXSPIKE becomes Moderna's third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).[1] "The... Read more
Study will assess relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA comparator at 12 months SOUTH SAN FRANCISCO, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the first patient was dosed in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine candidate. “Initiating dosing in the 10,000-participant... Read more
CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 variant LP.8.1. The submission is based on guidance from the U.S. FDA, which advised that COVID-19 vaccines should be updated to a monovalent JN.1 lineage, with a preference for the LP.8.1 variant. About Moderna Moderna is a... Read more
WALTHAM, Mass., May 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced that PEMGARDA® (pemivibart), its investigational monoclonal antibody, has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. NCCN joins the Infectious Disease Society of America (IDSA) that updated its COVID-19 guidelines in August 2024 to recommend the use of PEMGARDA (pemivibart) for pre-exposure... Read more
CAMBRIDGE, MA / ACCESS Newswire / May 21, 2025 / Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational... Read more
Nuvaxovid™ is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the U.S. Biologics License Application approval triggers $175 million Sanofi milestone payment, with additional COVID-19 vaccine milestones and ongoing tiered royalties to be recognized when earned GAITHERSBURG, Md., May 19, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics... Read more
Company’s PlaCCine® technology platform demonstrates better durability and other advantages compared to mRNA vaccines Results further validate PlaCCine as a novel vaccine platform with potential applications in COVID-19 and other infectious diseases with epidemic implications LAWRENCEVILLE, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapies and evaluating an adaptation... Read more
Preliminary data showed Novavax's non-mRNA JN.1 COVID-19 vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccine Full results will be submitted for publication later this year GAITHERSBURG, Md., April 15, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced preliminary results from the SHIELD-Utah study (Study of Healthcare Workers and First Responders Investigating Effects... Read more
Broader protection induced by combination of COVID adenovirus vaccine plus CiVax™ compared to 2-shot mRNA vaccination series PRINCETON, N.J., March 25, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today a publication describing the preclinical efficacy of CiVax™,... Read more
Preclinical and Phase 1 data suggest that ratutrelvir can be used without ritonavir and may reduce the likelihood of COVID rebound and the risk of long COVID due to a longer treatment regimen Preparations are underway for FDA interactions and initiation of Phase 2 studies Data presentation to be provided at the Investor Event on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws”... Read more
Long-lasting in vivo antibody production: DMAb levels remained stable for 72 weeks in all participants (n=24) who have reached that timepoint No anti-drug antibodies (ADA): no immune rejection of the DMAbs was detected across ~1,000 blood samples, unlike other gene-based antibody delivery approaches where ADA formation has been a challenge Well-tolerated: most common side effects were mild, temporary injection site reactions such as pain and redness; no serious... Read more
BERWYN, Pa. / Mar 07, 2025 / Business Wire / Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, is looking to use Molecular Envelope Technology (MET) or a similar technology to deliver a mRNA COVID vaccine. Virpax currently uses its MET for Envelta (NES100)... Read more
New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA™ (pemivibart) against LP.8.1 Centers for Disease Control reports LP.8.1, XEC and KP.3.1.1 together constitute the majority of current national SARS-CoV-2 variants; current dominant variants are all susceptible to PEMGARDA Pemivibart antiviral activity remains within the range of expected assay variability since Omicron BA.2; affirms structural biology within Invivyd’s... Read more
Results of IMNN-101 Proof-of-Concept study demonstrate persistent immunogenicity in trial participants and further validate PlaCCine® technology IMNN-101 induced 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4 IMNN-101 continues to show an acceptable safety profile LAWRENCEVILLE, N.J., Feb. 26, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy... Read more
NEW YORK, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that a nasal anti-CD3 (foralumab) preclinical study is nearing completion, and that foralumab could offer a novel and effective treatment for long COVID.... Read more
FDA’s reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral activity rather than equivalent antiviral activity to past, highly effective, previously authorized and now inactive COVID-19 mAbs in a bridging analysis of sVNA1 titer levels, otherwise the Agency is “unable to reasonably conclude that the known and potential benefits of pemivibart…outweigh the... Read more
The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component SALT LAKE CITY, Feb. 21, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the... Read more
KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials WALTHAM, Mass. & SAN DIEGO / Feb 14, 2025 / Business Wire / Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the European Commission has granted... Read more
Recruitment completed and all doses administered for VYD2311 ongoing Phase 1/2 clinical trial (40 subjects) evaluating 3 routes of administration Phase 1/2 clinical data for VYD2311 to date are positive for both safety and pharmacokinetics, and are supported by antiviral activity data from Invivyd's standard virologic assessments Pooled, blinded adverse events (AEs) to date are mild or moderate and thus far deemed unrelated to study drug or largely related to injection... Read more
TOKYO / Jan 31, 2025 / Business Wire / Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi) announced today that it has received approval for a partial amendment to the manufacturing and marketing approval of “KOSTAIVE® for Intramuscular Injection,” a self-amplifying mRNA vaccine for protection against COVID-19, to include domestic manufacturing sites in Japan. Meiji Seika Pharma and ARCALIS Co., Ltd.... Read more
Treatment immunobridging analysis, routinely updated for contemporary SARS-CoV-2 variants, compares pemivibart antiviral titers to adintrevimab antiviral titers from the company’s previous Phase 2/3 clinical trial of adintrevimab for the treatment of COVID-19 (STAMP), in which adintrevimab conferred a 66% to 74% reduction in risk of hospitalization or death from COVID-19 compared to placebo depending on time of therapy start Most recent updated analysis provided to... Read more
The Agreement provides participating countries with the opportunity to diversify their mRNA COVID-19 vaccine supply and gain access to pre-filled syringe vaccine formats CAMBRIDGE, MA / ACCESS Newswire / January 24, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has been awarded a tender for the supply of its mRNA COVID-19 vaccine in the European Union (EU), Norway and North Macedonia. Under the resulting agreement, 17 participating countries can access... Read more
COVID-19 Phase 2b study poised to initiate 10,000 participant portion of trial pending U.S. Food and Drug Administration (FDA) review of sentinel cohort 30-day safety data Norovirus program to proceed with Phase 1 study following scientific advisory board and FDA feedback; Trial to initiate the first half of 2025 with topline data expected as early as mid-2025 New avian influenza vaccine candidate being tested in preclinical studies SOUTH SAN FRANCISCO, Calif., Jan.... Read more
Independent Data Safety Monitoring Board (DSMB) recommends study to proceed without modifications based on initial safety assessment of 400 participant 30-day data The company plans to progress the trial to enrollment of 10,000 participants, upon favorable review from the U.S. Food and Drug Administration (FDA) and upon Biomedical Advanced Research and Development Authority (BARDA) approval SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc.... Read more
Company continuing to work with the U.S. FDA on potential for accelerated approval pathway Novavax intends to partner on both candidates to advance to filing and commercialization GAITHERSBURG, Md., Dec. 10, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone seasonal... Read more
FORT LAUDERDALE, FL / ACCESSWIRE / December 9, 2024 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that it has developed an orally active protease inhibitor with dose-dependent antiviral activity in mice infected with SARS Coronavirus (SARS-CoV-2). There are still unmet medical needs for agents to combat SARS-CoV-2... Read more
MOVe-NOW will build on existing LAGEVRIO data to assess efficacy in the current COVID-19 environment and support applications for licensure RAHWAY, N.J. & MIAMI / Dec 05, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the Phase 3 MOVe-NOW clinical trial to evaluate LAGEVRIOTM (molnupiravir), an investigational oral antiviral COVID-19 medicine, for the treatment of adults with COVID-19... Read more
SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced completion of enrollment of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. The sentinel cohort comprised of 400 participants, with 200 receiving Vaxart’s COVID-19 vaccine candidate and 200 receiving an approved mRNA vaccine comparator. “We are pleased to complete... Read more
GEO-CM04S1 Improved Immune Response vs mRNA Vaccine ATLANTA, Nov. 19, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, as a booster vaccine for... Read more
CANOPY manuscript preprint includes six-month off-drug follow-up period that highlighted strong protection by pemivibart versus placebo in the immunocompetent Cohort B during KP.3 and KP.3.1.1 dominant wave CANOPY exploratory clinical efficacy data, to date, reconfirm a high level of risk reduction from developing symptomatic COVID-19 in immunocompetent participants Preprint describes Invivyd scientists’ novel method for predicting the activity of a monoclonal antibody... Read more
GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the Company to begin enrolling the planned Phase 3 trial... Read more
Following strong protection (84% relative risk reduction versus placebo) demonstrated through month 6 with pemivibart, CANOPY clinical trial participants were followed for an additional six-month period (months 7-12), with no additional doses, to assess safety and efficacy as drug concentrations declined over time In the six-month off-drug follow-up period (months 7-12), substantially reduced concentrations of PEMGARDA reduced the risk of symptomatic COVID-19 by 64%... Read more
GAITHERSBURG, Md., Oct. 16, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The clinical hold is due to a spontaneous report of a serious adverse... Read more
GAITHERSBURG, Md., Oct. 9, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the European Commission granted Marketing Authorization for Novavax's updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU). This... Read more
