Of the 209 patients with tardive dyskinesia (TD) that were surveyed, >94% reported movement improvement once treated with AUSTEDO XR® (deutetrabenazine) extended-release tabletsPatients reported high satisfaction (>89%) with AUSTEDO XR, with 96% expressing interest in continuing treatmentAlmost all (>96%) patients relayed that AUSTEDO XR was easy to take PARSIPPANY, N.J. and TEL AVIV, Israel, Sept. 20, 2025 (GLOBE NEWSWIRE)...Read more
Through Week 56 in the SOLARIS trial, there were no suspected or confirmed post-injection delirium/sedation syndrome (PDSS) events observed with olanzapine LAI (TEV-'749) and its long-term systemic safety profile was consistent with other olanzapine formulations1Additional new data comparing initiation of UZEDY® (risperidone) versus Invega Sustenna® (paliperidone palmitate) in hospitalized patients found that UZEDY was associated with...Read more
Cemsidomide in Combination With Dexamethasone Achieved a 50% Overall Response Rate (ORR) at the Highest Dose Level (100 µg) and a 40% ORR at the 75 µg Dose Level in a Heavily Pre-Treated Relapsed/Refractory Multiple Myeloma Patient Population Responses Across Dose Levels With Median Duration of Response of 9.3 Months as of the Data Cut-off Date; Median Duration of Response Not Yet Reached at Two Highest Doses No Discontinuations Related...Read more
TREMFYA® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn's disease TREMFYA® achieved significant rates of clinical remission and endoscopic improvement versus placebo at Week 12 with a subcutaneous induction regimen, consistent with IV induction Johnson & Johnson is initiating a head-to-head study seeking to demonstrate the superiority of...Read more
100 percent of evaluable patients achieved minimal residual disease (MRD) negativity following induction therapy in updated results from the Phase 2 MajesTEC-5 study TORONTO, Sept. 19, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced that an investigational immune-based induction regimen with TECVAYLI® (teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) demonstrated meaningful clinical...Read more
KEYTRUDA QLEX is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute RAHWAY, N.J. / Sep 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for...Read more
If approved by the European Commission, ENFLONSIA will be the first and only RSV preventive option in Europe for administration to infants using the same dose regardless of weight RAHWAY, N.J. / Sep 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the...Read more
Positive opinion granted for SC administration of KEYTRUDA for all adult indications approved in the European Union for KEYTRUDA Positive opinion also granted for KEYTRUDA as part of a perioperative regimen for the treatment of certain adult patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) based on results of Phase 3 KEYNOTE-689 trial RAHWAY, N.J. / Sep 19, 2025 / Business Wire / Merck (NYSE:...Read more
The Implantable Tibial Neuromodulation (ITNM) device will expand treatment options for the 16 million people living with urinary urges and involuntary leaks GALWAY, Ireland, Sept. 19, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the Altaviva™ device. The minimally invasive implantable tibial...Read more
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Sep 19, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR) announced today that it will host a webcast to review data from the successful TETON-2 pivotal study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis (IPF) on Sunday, September 28, 2025, at 12:30 p.m. Eastern Time. During the...Read more
NEW YORK, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it will participate in a fireside chat at Bernstein’s 2nd Annual Healthcare Forum on Tuesday, September 23, 2025 at 2:50 p.m. ET. The webcast will be accessible from Royalty Pharma’s “Events” page at https://www.royaltypharma.com/investors/events/. The webcast will also be archived for a minimum of thirty days. About Royalty Pharma...Read more
CAMBRIDGE, MA / ACCESS Newswire / September 19, 2025 / Moderna announced today that the first mRNA vaccines fully manufactured in Canada are being shipped to provinces and territories. This milestone advances Canada's domestic vaccine production capacity and strengthens national health security. "The delivery of the first made-in-Canada mRNA vaccines to provinces and territories across the country marks a major milestone in our...Read more
CARLSBAD, Calif. / Sep 19, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Sobi® today announced that TRYNGOLZA® (olezarsen) has been approved in the European Union (EU) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). The approval follows the positive opinion of the Committee for Medicinal Products for Human Use. The approval is based on...Read more
REYKJAVIK, Iceland, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. (“Fuji Pharma”), has received marketing approval for three new biosimilars from the Japanese Ministry of Health, Labor and Welfare. The biosimilars approved...Read more
NEW YORK, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia were updated to include revumenib as a category 2A recommendation for relapsed or refractory (R/R) acute myeloid...Read more
IBTROZI will be marketed in Japan by Nippon Kayaku Approval is based on the pivotal Phase 2 TRUST studies, demonstrating IBTROZI's high rates and durability of responses Primary companion diagnostic approved in parallel NEW YORK / Sep 19, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that Japan’s Ministry of...Read more
neffy 1 mg and 2 mg doses approved by Japanese regulators neffy offers a new delivery method for epinephrine in Japan for adults and children (>15 kg) living with severe allergic reactions Alfresa Holdings, which owns the rights to market neffy in Japan, expects availability in Q4 2025 SAN DIEGO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering...Read more
Nearly 50% of individuals with severe GAD reported experiencing SI almost daily Findings highlight the link between anxiety severity and SI, underscoring the need for routine screening NEW YORK / Sep 19, 2025 / Business Wire / Researchers from Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders,...Read more
First European launch of EKTERLY expected in Germany Q4 2025 EKTERLY now approved in the US, EU, UK and Switzerland with additional regulatory applications under review in key global markets FRAMINGHAM, Mass. & SALISBURY, England / Sep 19, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the European Commission (EC) and Swiss Agency for Therapeutic Products, Swissmedic, have approved...Read more
GAITHERSBURG, Md., Sept. 19, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has secured new purchase orders from an international government partner for a multi-product supply agreement valued at $29 million (USD). The orders span several product offerings within Emergent’s medical countermeasures (MCM) business, including countermeasures for smallpox, anthrax and botulism threats, and reflects the...Read more
CARMEL, Ind., Sept. 19, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced that it will provide topline results from its Phase 2 clinical trial of potential once-weekly canvuparatide for patients with chronic hypoparathyroidism (HP) and...Read more
Novel CB1 inhibitor Phase 1b data highlights lack of neuropsychiatric adverse events and favorable gastrointestinal tolerability SAN DIEGO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced the presentation of results from the Phase 1b study of nimacimab...Read more
VANCOUVER, BC / ACCESS Newswire / September 19, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:XPHYF)(FSE:4XT) is pleased to announce that, further to its news release of September 12, 2025, it has closed its debt settlement with an arm's length creditor (the "Creditor") related to an aggregate of $225,010 in debt (the "Debt") owing for services provided by the Creditor to the Company. In full satisfaction...Read more
Live webcast presentation on Thursday, September 25th at 9:40 AM PT PRINCETON, N.J., Sept. 19, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing immunotherapeutic drugs targeted to the tumor microenvironment (TME), today announced that Raghu Rao, Interim Chief Executive Officer of Sonnet, will present on Thursday, September 25, 2025 at 9:40 AM...Read more
DUBLIN and CHICAGO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today provided a general business update. ORLYNVAHTM Launch Update In partnership with EVERSANA Life Science Services, LLC (“EVERSANA”), ORLYNVAH™ was...Read more
Leading breast surgical oncologist Dr. Amelia Tower to present on wide-field optical coherence tomography for margin visualization during breast conserving surgery TORONTO and DALLAS, Sept. 19, 2025 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, announced that Dr. Amelia Tower, a leading breast surgical oncologist...Read more
Patent covers advanced signal processing for middle ear sensors, further advancing the Company's position in leveraging the ear for fully implanted hearing devices White Bear Lake, Minnesota--(Newsfile Corp. - September 19, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted hearing solutions, today announced that it has received an Issue...Read more
Enhanced Brain Biodistribution of GLP-1 Drugs May Be Related to Improvements in Safety and Efficacy KELOWNA, BC / ACCESS Newswire / September 19, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce successful results from its fluorescently tagged semaglutide ("FTS") rodent biodistribution study (the "Study"). The main goal of...Read more
OVATION 3 pivotal Phase 3 trial is currently advancing IMNN-001, with several patients being treated LAWRENCEVILLE, N.J., Sept. 19, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that new translational data from the Phase 2 OVATION 2 Study of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed...Read more
Toronto, Ontario--(Newsfile Corp. - September 19, 2025) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo"), a leader in the development of diagnostic and prognostic tests for human disease through the analysis of telomeres, today announced that the company has presented a poster abstract on minimal residual disease ("MRD") during the 22nd International Myeloma Society Annual Meeting in Toronto, Canada. The...Read more
Ra’anana, Israel, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced the submission of its full pre-submission (Pre-Sub) package to the U.S. Food and Drug Administration (FDA) for its PL-14 product, designed to help individuals suffering from nasal allergies. The submission includes comprehensive...Read more
The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for AIRSUPRA WILMINGTON, Del. / Sep 18, 2025 / Business Wire / AIRSUPRA’s US Prescribing Information now includes clinically meaningful evidence from the BATURA study in patients with mild asthma.1 The BATURA Phase IIIb trial, which evaluated severe exacerbation risk reduction, examined the efficacy of as-needed AIRSUPRA compared to...Read more
First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. Expands access to advanced testing with a fully automated, standardized workflow on the cobas® i 601 analyzer Marks an important step in broadening the clinical utility of mass spectrometry testing across routine labs INDIANAPOLIS, Sept. 18, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:...Read more
Ozempic® (once-weekly injectable semaglutide) was associated with a 23% reduced risk of heart attack, stroke and death in people with type 2 diabetes and cardiovascular disease on Medicare versus dulaglutide1 Data also highlighted Ozempic® was associated with a 26% lower risk of death versus dulaglutide1 This study is the first to directly compare these glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications in...Read more
CASGEVY is the first, and only, gene editing therapy approved for the treatment of transfusion-dependent beta thalassemia (TDT) and sickle cell disease (SCD) in Europe Italy has the largest population of people living with TDT in Europe LONDON / Sep 18, 2025 / Business Wire / Vertex Pharmaceuticals (Nasdaq: VRTX) announced today a reimbursement agreement with the Italian Medicines Agency (AIFA) for eligible...Read more
Biogen to drive end-to-end development and commercialization of ThecaFlex DRx™, an investigational implantable device for intrathecal delivery of antisense oligonucleotides (ASOs) ThecaFlex DRx™ has the potential to be a new, convenient way to administer medicines to patients living with neurological disorders. CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the company has entered into a...Read more
Implementation will enable users to purchase, schedule appointments for testing, and receive results of lab tests performed by Quest within the WHOOP app, supporting access to deeper health and performance insights. BOSTON / Sep 18, 2025 / Business Wire / WHOOP, the human performance company, today announced that Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, will be the U.S. lab provider for...Read more
Opzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis (AD) Phase 3 data supporting the approval show that treatment with Opzelura resulted in significant efficacy, with no new safety concerns identified This milestone marks the third U.S. approval for Opzelura, which is now indicated to treat mild to moderate AD in non-immunocompromised patients 2+ years of age and nonsegmental vitiligo in...Read more
Long-Term Data from FOREST-HCM in Non-Obstructive HCM and Results from Prespecified Analysis of MAPLE-HCM to be Presented in Late-Breaking Clinical Research Session SOUTH SAN FRANCISCO, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three upcoming presentations, including two Late Breaking Clinical Research presentations and one poster presentation, at the Heart Failure...Read more
GAITHERSBURG, Md. / Sep 18, 2025 / Business Wire / GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the appointment of Thomas Fuchs, Dr.sc., Chief AI Officer at Eli Lilly and Company, to its board of directors. “With the world’s largest rare disease data set, we’re only beginning to realize AI’s full potential to deliver faster, more precise insights to clinicians and families,...Read more
89bio stockholders to receive up to $20.50 per share in cash, comprised of $14.50 per share in cash at closing and a non-tradeable contingent value right (CVR) to receive up to an aggregate of $6.00 per share in cash; transaction represents total equity value of up to approximately $3.5 billion Transaction reflects pegozafermin’s potential best-in-disease profile for the treatment of moderate to severe metabolic...Read more
NASHVILLE, Tenn., Sept. 18, 2025 /PRNewswire/ -- Brookdale Senior Living Inc. (NYSE: BKD) ("Brookdale" or the "Company") announced today that Company management will participate in the 2025 Jefferies Healthcare Services Conference on September 30, 2025. The Brookdale fireside chat will begin at 8:00 am CST, and the live webcast can be accessed through the Company's website at brookdaleinvestors.com as well as by clicking here. A...Read more
Completed patient enrollment within nine months with nearly half enrolled from the U.S. Expect to report Phase 3 topline data in the first half of 2026 On track to submit BLA in the second half of 2026 for an anticipated U.S. launch in the first half of 2027 Plan to present additional data from the Phase 1/2 study in the fourth quarter of 2025 CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics,...Read more
Study met primary and key secondary endpoints at week 16 in patients with moderate-to-severe atopic dermatitis High dose rezpegaldesleukin achieved statistical significance on multiple patient-reported outcome assessments at completion of 16-week induction period Interim data presented for patients who received placebo during induction period and crossed over to receive 24 weeks of treatment with high dose rezpegaldesleukin show...Read more
NEW HAVEN, Conn., Sept. 18, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced that data from the Phase 2a RIVER trial...Read more
ALAMEDA, Calif. / Sep 18, 2025 / Business Wire / Infinimmune, a biotechnology company pioneering human-first antibody discovery and design, today announced a research collaboration agreement with Immunome, Inc. (NASDAQ: IMNM) for the discovery and optimization of novel antibodies. Under the agreement, Immunome will receive target exclusivity. Financial terms of the deal were not disclosed. Infinimmune rapidly optimizes and engineers early...Read more
MIPLYFFA, the only therapy for Niemann-Pick disease type C (NPC) shown to stop disease progression at 12 months, has been administered to more than 270 patients, representing the largest data set of NPC clinical trial patients OLPRUVA offers the established efficacy and safety of sodium phenylbutyrate in a novel and convenient formulation for the treatment of certain urea cycle disorders CELEBRATION, Fla., Sept. 18, 2025 (GLOBE...Read more
HEALWELL's subsidiary Intrahealth Systems Limited ("Intrahealth") has been selected by Public Health Sudbury & Districts ("Public Health") to implement Profile, its enterprise-grade electronic medical record ("EMR") platform. The deployment will equip Public Health with advanced digital tools to strengthen efficiency, support infectious disease control, vaccination, family health, oral health, sexual health, and environmental...Read more
Enhanced Affiliated Pharmacy Capabilities Support Specialized Therapies, Seamless Patient Experience, and Margin Expansion NEW YORK, Sept. 18, 2025 (GLOBE NEWSWIRE) -- LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care services, today announced the expansion of its state-of-the-art affiliated pharmacy to include advanced non-sterile compounding capabilities for oral and topical medications. This milestone extends...Read more
Results were published in JACC: Basic to Translational Science Publication evaluated coronary tissue engineered vessel (CTEV) as a conduit for CABG in a nonhuman primate model All implanted CTEVs remained patent through six months, demonstrated adaptive remodeling, and recellularized with host coronary artery cells Humacyte plans to advance CTEV into first-in-human study in CABG DURHAM, N.C., Sept. 18, 2025...Read more
PIPE-791 achieved high LPA1 brain receptor occupancy (RO) in healthy volunteers and progressive multiple sclerosis (PrMS) patients PIPE-791 showed a safety and tolerability profile consistent with previous clinical studies Topline data affirms planned doses for future Phase 2 clinical proof-of-concept trials SAN DIEGO / Sep 18, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a...Read more
Collaboration spans workers' compensation, nursing homes, and outpatient clinics PETACH TIKVA, Israel, Sept. 18, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD ("Nanox" or the "Company", Nasdaq: NNOX), an innovative medical imaging technology company, today announced a collaboration between its U.S. subsidiary Nanox Impact Inc. and Monarch Medical Management and Billing LLC (“Monarch”), an experienced healthcare management organization...Read more
WOBURN, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) on September 16th to discuss the complete response letter (CRL) for the Company’s Biologics License Application (BLA) for RP1 in combination...Read more
Tonix anticipates filing the IND application in the fourth quarter of 2025 TNX-102 SL is a potential first-in-class treatment for targeting the disturbed sleep associated with depression TNX-102 SL is FDA-approved for the treatment of fibromyalgia CHATHAM, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of...Read more
DENVER & MAHWAH, N.J. / Sep 18, 2025 / Business Wire / ForCast Orthopedics, Inc. and KORU Medical Systems, Inc. (NASDAQ: KRMD) today jointly announced an agreement leveraging KORU Medical’s FreedomEDGE® infusion system as part of ForCast’s technology platform for the treatment of periprosthetic joint infection (PJI). PJI is a rare but serious complication of joint replacement procedures, and is challenging to treat because the infecting...Read more
STAFFORD, Texas, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Ireland. The Company's application to European regulators has been formally...Read more
Donnelly brings more than 25 years of biopharmaceutical expertise in CMC and regulatory operations SEATTLE and VANCOUVER, British Columbia, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced the promotion of Craig...Read more
Intellectual property portfolio now includes 228 Patents and 153 Trademarks providing robust protection for the Company's product platforms in the rapidly growing multi-billion dollar veterinary diagnostics market ANN ARBOR, MI / ACCESS Newswire / September 18, 2025 / Zomedica Corp. (OTCQB:ZOMDF) ("Zomedica" or the "Company"), an animal health company offering innovative point-of-care diagnostic and therapeutic device products for...Read more
The invention is designed to improve cryoprobe extraction, further reducing risk of tissue trauma, leading to lower costs and improved patient experience XSense™ System with Cryoprobes recently received regulatory approval in the U.S. and Israel CAESAREA, Israel, Sept. 18, 2025 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation...Read more
TORONTO, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development, announces...Read more
On track for first FDA Biologics License Application (BLA) approved cell therapy in orphan indication relapsed/refractory AL Amyloidosis – Los Angeles, CA, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that 50% enrollment milestone has already...Read more
The Company plans to use the proceeds to accelerate the development of Teverelix, a next generation GnRH Antagonist, as a first in class market product for Acute Urinary Retention (AURr) and high CV risk Prostate Cancer collecting representing ~ $6 billion in potential market opportunity PHILADELPHIA, PA / ACCESS Newswire / September 18, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences...Read more
MISSISSAUGA, Ontario / Sep 18, 2025 / Business Wire / Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV; OTCQX: CVALF), an advanced medical technologies company, announced its participation at the Association for Vascular Access (AVA) Annual Scientific Meeting in Orlando, Florida, from September 18–21, 2025. Attendees will have the opportunity to explore Covalon’s innovative vascular access and infection prevention solutions...Read more
Extension of the Phase 1b study will allow participants to continue dosing with GT-02287 for an additional nine months after completing the first 90-day dosing schedule The Phase 1b study enrolled 21 subjects and the last participants will complete 90 days of dosing in December 2025 Early results from the Phase 1b study to be presented at the International Congress of Parkinson’s Disease (PD) and Movement Disorders in...Read more
New in vitro results show Telomir-1 adds KDM5 family inhibition to its previously reported KDM2/KDM6 and DNA methylation activity, potentially representing a novel frontier in epigenetic therapy where no existing candidates have shown comparable breadth. MIAMI, FLORIDA / ACCESS Newswire / September 18, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a preclinical-stage biotechnology company developing therapies that target the...Read more
First combination therapy to report 29.5 months of Median Overall Survival (mOS); Standard of care Keytruda® (pembrolizumab) alone (10.8 months) and Keytruda® + chemotherapy (12.3 months) in patients with CPS 1-19* Encouraging efficacy signal observed in difficult to treat category of advanced head and neck cancer patients PRINCETON, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech”...Read more
Grant of First Method of Use Patent Adds New Pillar to Grace’s Multi-layered Intellectual Property and Potential Market Exclusivity Protection Patent Coverage Extended to 2043 PRINCETON, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed...Read more
Certification critical to broad U.S. market release of the CNSide CSF Assay Platform CNSide now meets key federal and state regulatory requirements, including those set by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Lab Improvement Amendments (CLIA) HOUSTON, Texas, Sept. 18, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV)...Read more
REDWOOD CITY, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (“Jasper”), a clinical-stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting KIT (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, announced today that it intends to offer and sell in an underwritten public...Read more
RA'ANANA, Israel, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," “Inspira Technologies,” or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced it will present its HYLA blood sensor (“HYLA”) to the global medical community for the first time. The presentation will take place at the U.S. ELSO Annual Conference in Washington, D.C., between...Read more
Live webcast presentation on Wednesday, September 24th at 9:55 AM PT SOUTH SAN FRANCISCO, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that Kanya Rajangam, M.D., Ph.D., President, Head of Research & Development and Chief Medical...Read more
CUPERTINO, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that it intends to offer shares of its common stock (or common stock equivalents in lieu thereof) and...Read more
SALT LAKE CITY, Sept. 18, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced the closing of its previously announced registered direct offering pursuant to a securities purchase agreement with two institutional investors for the purchase and sale of...Read more
Interim efficacy analysis highlights potential value of combination therapy of apalutamide and ENV105 following positive safety data Company to host virtual KOL discussion today to provide additional perspective on data and the Company’s lead program LOS ANGELES / Sep 18, 2025 / Business Wire / Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today...Read more
SANTA ANA, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the 3rd China Great Bay Cell and Gene Therapy Forum,...Read more
Key updates to include advances made in the on-going clinical trial for INTASYL siRNA lead product candidate PH-762 King of Prussia, Pennsylvania--(Newsfile Corp. - September 18, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics using its proprietary INTASYL® siRNA gene silencing technology to eliminate cancer. Phio today announced that Phio Pharmaceuticals is a...Read more
SUNNYVALE, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial. Results from the open label roll-in cohort patients having chronic myocardial ischemia with...Read more
Training platform accelerates onboarding, expands distribution potential and better positions Company for growth TYLER, Texas / Sep 18, 2025 / Business Wire / NanoVibronix, Inc. (NASDAQ: NAOV) (“NanoVibronix” or the “Company”), a medical technology company specializing in non-invasive therapeutic systems, today announced the launch of Oscar, an advanced training aid, introduced through its ENvue Medical (“ENvue” or “ENvue Medical”)...Read more
EDEN PRAIRIE, Minn., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc., a fluid management company, today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,415,021 on September 16, 2025, based on Application No. 18/298,860. The patent relates to the use of one or more hemolysis sensors with extracorporeal blood filtration systems—such as ultrafiltration therapy and continuous renal replacement...Read more
CAMBRIDGE, Mass. / Sep 18, 2025 / Business Wire / Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced the closing of its previously announced exercise of certain outstanding series A warrants to purchase up to an aggregate of 1,212,499 shares of common stock of the Company...Read more
In SURPASS-PEDS, Mounjaro met the primary and all key secondary endpoints at 30 weeks and showed sustained improvement in glycemic control and continued BMI reduction through the study's 52-week extension The safety and tolerability profile of Mounjaro was generally consistent with previous adult studies INDIANAPOLIS, Sept. 17, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from...Read more
For the primary endpoint, orforglipron lowered A1C by 2.2% vs. 1.4% with oral semaglutide at the highest doses Participants taking the highest dose of orforglipron lost an average of 19.7 lbs (9.2%) vs. 11.0 lbs (5.3%) with oral semaglutide, a 73.6% relative improvement, in a key secondary endpoint The safety and tolerability of orforglipron were consistent with previous trials INDIANAPOLIS, Sept. 17, 2025 /PRNewswire/ -- Eli...Read more
Icotrokinra demonstrated superior skin clearance at Weeks 16 and 24 compared to deucravacitinib and similar adverse event rates to placebo in Phase 3 ICONIC-ADVANCE studies Icotrokinra also showed sustained skin clearance and favorable safety profile in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study Robust findings continue to demonstrate the potential of icotrokinra to disrupt the treatment paradigm to set a new...Read more
Subcutaneous administration of first-in-class biologic SAPHNELO demonstrates statistically significant and clinically meaningful reduction in disease activity WILMINGTON, Del. / Sep 17, 2025 / Business Wire / Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus (SLE) showed that the subcutaneous (SC) administration of AstraZeneca’s SAPHNELO®...Read more
Oral semaglutide 25 mg (the once-daily pill formulation of Wegovy®) achieved significant weight loss, with one in three study participants losing 20% or more body weight1** Oral semaglutide 25 mg also demonstrated improvements in the ability to perform everyday physical activities such as bending, standing, walking, being physically active, and improvements in cardiovascular risk factors1 Oral semaglutide 25 mg is the first oral GLP-1...Read more
FOP is a disease in which muscles, tendons and ligaments are progressively replaced by bone, leading to eventual incapacitation Garetosmab is the first and only treatment to demonstrate a dramatic reduction in both number and volume of abnormal bone lesions (heterotopic ossification, or HO lesions) in adults with FOP Primary endpoint was met, showing a 90% or greater reduction in new HO lesions at 56 weeks, and garetosmab also led to...Read more
Complete 26-week results further demonstrate that combining semaglutide with trevogrumab (anti-GDF8/anti-myostatin) helped prevent about half of semaglutide-induced loss of lean mass, while increasing fat mass loss Numeric improvements in metabolic and lipid parameters including waist circumference, blood pressure, cholesterol, triglycerides and A1C, were observed across all treatment groups TARRYTOWN, N.Y., Sept. 17, 2025 (GLOBE...Read more
LOUISVILLE, Ky. / Sep 17, 2025 / Business Wire / A new study published in The New England Journal of Medicine Catalyst, conducted by the Humana Healthcare Research team and Massachusetts General Hospital Attending Physician Dr. Suhas Gondi, who completed the research while a resident physician at Harvard Medical School's Brigham and Women's Hospital, finds that patients who receive care from senior-focused primary care organizations that...Read more
Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up to 20% of women experience postpartum depressive symptoms6-11 The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPD The EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from...Read more
Across both STOP-HS1 and STOP-HS2, povorcitinib treatment resulted in continued clinically meaningful and statistically significant improvements for patients with active moderate to severe hidradenitis suppurativa (HS) through Week 24 At Week 24, nearly 60% of efficacy-evaluable patients among both povorcitinib treatment groups achieved HiSCR50 Additionally, patients treated with povorcitinib achieved HiSCR75 (31.0%-40.3%), HiSCR90...Read more
Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onset On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo...Read more
Universal Surveillance Monitoring with Masimo SET® Pulse Oximetry and Patient SafetyNet™ – Repeatedly Shown to Improve Patient Outcomes and Save Lives – Also Projected to Yield Significant Cost Savings IRVINE, Calif. / Sep 17, 2025 / Business Wire / Masimo (NASDAQ: MASI) today announced the findings of a study published in the Journal of Patient Safety in which Dr. George Blike and colleagues at Dartmouth-Hitchcock Medical Center in...Read more
Six poster presentations showcase clinical and real-world data in major depressive disorder, Alzheimer’s disease agitation, narcolepsy, and obstructive sleep apnea NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced six presentations across its broad portfolio of innovative...Read more
Icotrokinra demonstrated superior skin clearance at Weeks 16 and 24 compared to deucravacitinib and similar adverse event rates to placebo in Phase 3 ICONIC-ADVANCE studies Icotrokinra also showed sustained skin clearance and favorable safety profile in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study Preclinical proof-of-concept data on PN-881, a first-in-class oral peptide targeting the IL-17 pathway, and part of...Read more
Featured presentations showcase the positive Phase 1 healthy volunteer trial results supporting KT-621’s oral, dupilumab-like profile KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) patients on track to report data in 4Q25 KT-621 Phase 2b trials in AD and asthma on track to initiate in 4Q25 and 1Q26, respectively WATERTOWN, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ:...Read more
CAMBRIDGE, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that 48-week clinical data from the Phase 3 study in China evaluating telitacicept in adults with generalized myasthenia gravis, a study sponsored by Vor’s collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), will be presented as an oral presentation at...Read more
New analysis of ZORYVE foam 0.3% demonstrates reduction in signs and symptoms of seborrheic dermatitis in individuals with diverse skin types New data show improved quality of life and decreased impact on families for investigational ZORYVE cream 0.05% in children aged 2–5 years with atopic dermatitis Data demonstrate both ZORYVE cream 0.3% and ZORYVE foam 0.3% improved signs and symptoms of plaque psoriasis in individuals with facial...Read more
- Efficacy and safety results from successful NAVIGATE Phase 2b trial of CD388 for prevention of influenza illness featured in late-breaking presentation - Preclinical data demonstrating potential efficacy of CD388 to prevent H5N1 infection featured in oral presentation SAN DIEGO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to...Read more
Rapid and sustained efficacy regardless of baseline IgE levels in patients with CSU HAMPTON, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data demonstrating rapid and strong efficacy regardless of baseline immunoglobulin E (IgE) levels in patients with chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast...Read more
REDWOOD CITY, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2025. “We have made substantial progress this year across our two indications for ersodetug in both...Read more
Data support advancement of GS-6791 into clinical testing in patients with inflammatory diseases; first-in-human Phase 1 trial in healthy volunteers is ongoing Data are being presented at the European Academy of Dermatology and Venereology (EADV) Congress SAN FRANCISCO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX) today announced the presentation of preclinical data from GS-6791/NX-0479, a novel...Read more
Pilavapadin 10 mg resulted in a two-point reduction from baseline in average daily pain scores (ADPS) by week 11 and was well tolerated in PROGRESS Phase 2b study THE WOODLANDS, Texas, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the presentation of clinical data from the company’s Phase 2b PROGRESS study for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of...Read more
Results Support Potential for STAR-0310 to be Best-in-Class OX40 Antagonist STAR-0310 Exhibits Longest-in-Class Half-Life of 68 Days and Cytokine Suppression Lasting At Least 20 Weeks After a Single 300 mg SC Injection, Supporting Potential Every-Six-Month Administration STAR-0310 Was Well-Tolerated, with no ADCC-Related Treatment-Emergent Adverse Events, Supporting a Wider Therapeutic Window with the Potential to Drive...Read more
NEEDHAM, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that an abstract was accepted for an oral presentation at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place from September 27 to October 1,...Read more
Positive Phase 1 study showed safety, tolerability and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1) Planning adaptive Phase 2/3 study Approximately 70 million people that are eligible for treatment live in areas of the U.S. in which Lyme Disease is endemic CHATHAM, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated...Read more
Denifanstat met all primary and secondary endpoints versus placebo Denifanstat was generally well tolerated Sagimet initiated first-in-human Phase 1 clinical trial of a second FASN inhibitor, TVB-3567, for development in acne SAN MATEO, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and...Read more
The study, published in The European Journal of Ophthalmology, included 29 publications and concluded that favorable long-term safety and efficacy profiles make OMNI a beneficial treatment option for patients with primary open-angle glaucoma MENLO PARK, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) (Sight Sciences or the Company), an eyecare technology company focused on developing and commercializing...Read more
ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results T cell responses included both mKRAS-specific CD4 and CD8 T cells in 85% of patients BOSTON,...Read more
Over 5 million New York Medicaid members to gain access to Transcranial Magnetic Stimulation (TMS) services MALVERN, Pa., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders and the maker of NeuroStar® Advanced Therapy, the leading provider of...Read more
Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking’s research and development activities leverage...
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ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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