12-Month Parasiticide Treatment for Dogs Offers Unrivaled Duration of Flea and Tick Protection Compared to Existing Products RAHWAY, N.J. / Jul 10, 2025 / Business Wire / Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and Drug Administration (FDA) approval of BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension)... Read more
ISB 2001 is currently in Phase 1 clinical trial in patients with relapsed/refractory multiple myeloma (R/R MM) NORTH CHICAGO, Ill. and NEW YORK, July 10, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation, Inc. (IGI), today announced an exclusive licensing agreement for IGI's lead investigational asset, ISB 2001, developed using IGI's proprietary BEAT® protein platform, for... Read more
XTANDI: the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR) NEW YORK & TOKYO / Jul 10, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive topline results from the overall survival (OS) analysis from the Phase... Read more
Doravirine/islatravir would be the first FDA-approved two-drug regimen without an integrase inhibitor that demonstrated non-inferior efficacy and a generally comparable safety profile to the three-drug InSTI-based regimen, BIC/FTC/TAF, in a Phase 3 pivotal trial RAHWAY, N.J. / Jul 10, 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 accepted for review... Read more
GSK supports seasonal flu immunization in the US by shipping FLULAVAL (Influenza Vaccine) and FLUARIX (Influenza Vaccine) in advance of flu season PHILADELPHIA / Jul 10, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its trivalent seasonal influenza vaccines to US healthcare providers and pharmacies in preparation for the 2025-26 flu season. This immediately follows a licensing and lot-release approval from the US... Read more
The first approval worldwide for elinzanetant, under the brand name LynkuetTM (Lynkuet®* in the UK), for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause is based on results from the three pivotal trials in the OASIS Phase III clinical development program1 / Elinzanetant is the first dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) and has demonstrated a significant mean reduction... Read more
Acquisition aligns with Merck’s science-led business development strategy and expands pipeline and portfolio of treatments for cardio-pulmonary diseases Merck to hold investor call at 8 a.m. ET today RAHWAY, N.J. & RALEIGH, N.C. / Jul 09, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceutical company focused on respiratory diseases, today announced... Read more
Strategic Partnership Agreement is Part of Gilead’s Commitment to Provide Lenacapavir at No Profit in High-Incidence, Resource-Limited Countries Until Licensed Generics Can Fully Meet Demand FOSTER CITY, Calif. / Jul 09, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to supply lenacapavir—Gilead's twice-yearly injectable... Read more
The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding to the established safety profile of the treatment INDIANAPOLIS, July 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy... Read more
Bagsværd, Denmark, 8 July 2025 – Novo Nordisk today announced the submission of an application to the European Medicines Agency (EMA) for approval of a new, higher dose of its obesity treatment, Wegovy® (subcutaneous semaglutide 7.2 mg). This marks another significant milestone in the company’s goal to provide a broad portfolio of innovative and person-centric solutions to support people living with obesity, as part of their journey towards better health. The... Read more
Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy With the addition of CAPLYTA® to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults... Read more
The GCAptAIN study did not meet its primary endpoint of sustained remission at Week 52 in adults with newly diagnosed or relapsing GCA1 Safety in GCA patients was consistent with known safety profile of Cosentyx® (secukinumab)1 EAST HANOVER, N.J., July 3, 2025 /PRNewswire/ -- Novartis today announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA). In... Read more
TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Lynozyfic... Read more
RAHWAY, N.J. / Jul 02, 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 accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the treatment of adults with pulmonary... Read more
OXLUMO has been shown to significantly reduce urinary oxalate, which drives the progression of PH1 Disease1 MISSISSAUGA, ON, July 2, 2025 /CNW/ - Alnylam Canada ULC is pleased to announce that OXLUMO® (lumasiran) is now funded across Canada through both public and private plans. OXLUMO is an RNA interference (RNAi) therapeutic administered via subcutaneous injection, indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels... Read more
SAN DIEGO, June 30, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of investigational compound NBIP-01435 in healthy adult participants. NBIP-01435 is a long-acting corticotropin-releasing factor type 1 receptor antagonist administered as a subcutaneous injection for the potential treatment... Read more
At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone THOUSAND OAKS, Calif., June 30, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. Bemarituzumab plus... Read more
Capstan's lead asset, CPTX2309, is a targeted lipid nanoparticle (tLNP) that delivers an mRNA encoding an anti-CD19 chimeric antigen receptor (CAR) to CD8-expressing cytotoxic T cells in vivo, and is a potential first-in-class product for treating B cell-mediated autoimmune diseases Proposed acquisition strengthens AbbVie's commitment to transforming the future of patient care with Capstan's innovative tLNP platform technology NORTH CHICAGO, Ill. and SAN DIEGO, June... Read more
GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with Less Than or Equal to 2 µg/mL IgA in a 10% Solution is Approved for Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency1 U.S. Commercialization of GAMMAGARD LIQUID ERC Projected to Begin in 2026 Company Announces Future Manufacturing Discontinuation End Date for Takeda's First-Generation Low-IgA Product, A Freeze-Dried Formulation in Company’s Differentiated Immunoglobulin... Read more
Global Phase 3 PROMINENT study will evaluate the efficacy and safety of felzartamab, as compared to tacrolimus, in adults with primary membranous nephropathy (PMN) There are currently no therapies specifically approved for PMN, a rare immune-mediated disease affecting the kidneys with an estimated prevalence of ~36k patients in the U.S.1 Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potentially differentiated therapeutic candidate with promise... Read more
mRNA-1010 demonstrated superior relative vaccine efficacy that was 26.6% (95% CI; 16.7%, 35.4%) higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older CAMBRIDGE, MA / ACCESS Newswire / June 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the Company's seasonal influenza (flu) vaccine... Read more
Phase 1b study supports proof-of-concept in DOK7 congenital myasthenic syndromes Decision informed by favorable safety profile and consistent functional improvement over time across multiple efficacy measures Advancing ARGX-119 further validates strong track record of Immunology Innovation Program (IIP), argenx's collaborative discovery model June 30, 2025, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology... Read more
SKINVIVE by JUVÉDERM® is currently approved in the U.S. as the first and only hyaluronic acid microdroplet injectable indicated to improve cheek skin smoothness. If approved, SKINVIVE by JUVÉDERM® will be the first hyaluronic acid injectable treatment option aiming to reduce neck lines. The application for indication expansion is supported by a clinical study that met all primary and secondary endpoints assessing SKINVIVE by JUVÉDERM® in adults with... Read more
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access Only about 2 in 10 eligible patients currently receive cell therapy treatment; today’s announcement will reduce unnecessary barriers for patients and providers PRINCETON, N.J. / Jun 26, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY)... Read more
Study demonstrates superiority, showing both statistically significant and clinically meaningful reduction in annualized bleeding rate with a generally well-tolerated safety profile compared to on-demand treatment in patients 12 years and older HYMPAVZI was administered with a straightforward, once-weekly subcutaneous injection that required minimal preparation NEW YORK / Jun 26, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive topline results... Read more
Novo Nordisk announces collaboration with WeightWatchers to offer patients living with obesity access to FDA-approved Wegovy® through NovoCare® Pharmacy Ro and LifeMD collaborations continue based on their commitment to providing safe and effective medical treatment for patients living with chronic diseases; dialogue with other companies ongoing A new $299 savings offer, available from July 1 – July 31, 2025, is designed to help new self-paying patients previously... Read more
MR-141 Met Primary And All Secondary Endpoints, Demonstrating Rapid And Sustained Improvement In Near Visual Acuity Without Compromising Distance Vision Safety Profile Consistent With Previous Clinical Trials And No Treatment-Related Serious Adverse Events Reported In This Study Targeting Application To U.S. FDA In Second Half of 2025 PITTSBURGH, June 26, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive... Read more
ENFLONSIA is the first and only RSV preventive option for administration to infants using the same dose regardless of weight Ordering will begin in July, with shipments delivered before the start of the 2025-2026 RSV season RAHWAY, N.J. / Jun 26, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted... Read more
Salanersen (BIIB115/ION306) is a novel antisense oligonucleotide (ASO) with the potential to achieve high efficacy and once yearly dosing in spinal muscular atrophy (SMA) Interim Phase 1 data show children with SMA previously treated with gene therapy experienced a substantial slowing of neurodegeneration and clinically meaningful improvements in motor function following initiation of salanersen Based on these encouraging Phase 1 data, Biogen is engaging with regulators... Read more
FOSTER CITY, Calif. & WATERTOWN, Mass. / Jun 25, 2025 / Business Wire / Gilead Sciences, Inc. (NASDAQ: GILD) and Kymera Therapeutics, Inc. (NASDAQ: KYMR), today announced that they have entered into an exclusive option and license agreement to accelerate the development and commercialization of a novel molecular glue degrader (MGD) program targeting cyclin-dependent kinase 2 (CDK2) with broad oncology treatment potential including in breast cancer and other solid tum... Read more
With this approval, pediatric patients aged five years and older with active lupus nephritis will have a first-of-its-kind treatment option for at-home administration. PHILADELPHIA / Jun 24, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients... Read more
Based on TROPION-Lung05 results and supported by data from TROPION-Lung01 First and only TROP2-directed therapy approved in the US for the treatment of lung cancer WILMINGTON, Del. / Jun 24, 2025 / Business Wire / DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based c... Read more
MINNEAPOLIS, June 24, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced a distribution agreement with the U.S. Pharmacopeia (USP) that enables the Company to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards with its analytical solutions, including the Maurice system, to support monoclonal antibody and gene therapy development around the world. More than 160 antibody therapies against nearly 100... Read more
A phase 1 study of miroliverELAP for the treatment of acute liver failure is currently underway;1 first patient in the study underwent the procedure at Intermountain Medical Center in Murray, Utah Approximately 30% of acute liver failure (ALF) patients die without access to a liver transplant.2 EDEN PRAIRIE, Minn. & MURRAY, Utah / Jun 24, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, and Intermountain Health,... Read more
Pending a decision from the European Commission, Ozempic® (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar, weight, cardiovascular (CV) events, chronic kidney disease and peripheral arterial disease (PAD) functional outcomes1. Ozempic® is the first and only glucose-lowering treatment with proven functional benefits in people with type 2... Read more
MariTide, the First Monthly or Less Frequently Dosed Obesity Treatment, Demonstrated Up to ~20% Average Weight Loss Without a Weight Loss Plateau, and Delivered Significant Cardiometabolic Improvements at 52 Weeks In People Living With Obesity With Type 2 Diabetes, MariTide Demonstrated Up to ~17% Average Weight Loss and Robust HbA1c Improvements Dose Escalation With Lower Starting Doses Substantially Improved Gastrointestinal Tolerability, Without Compromising Ef... Read more
Ralinepag has the potential to be the first once-a-day oral prostacyclin agonist for patients with pulmonary arterial hypertension ADVANCE OUTCOMES will continue to accrue clinical worsening events through the end of 2025 and top-line data is expected in the first half of 2026 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Jun 23, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced the conclusion of... Read more
WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy HYPERION, third Phase 3 study to demonstrate significant efficacy in adults with PAH, was previously stopped early based on review of available data from clinical program RAHWAY, N.J. / Jun 23, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive... Read more
Exclusive collaboration and license agreement for povetacicept in these countries Ono will leverage its deep expertise in clinical development and commercialization for chronic kidney disease in Japan and South Korea to accelerate advancement of povetacicept for patients with IgA nephropathy and primary membranous nephropathy BOSTON & OSAKA, Japan / Jun 23, 2025 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Ono Pharmaceutical... Read more
New FRONTIER5 data show that a direct switch to investigational Mim8 (denecimig) prophylaxis treatment from emicizumab, without the need for a washout period, was well-tolerated with no safety concerns in adults and adolescents with haemophilia A, with or without inhibitors1. Switching to Mim8 led to a sustained increase in thrombin generation into the normal range, but without causing thrombin levels that might pose a thrombotic risk1. FRONTIER5 Patient-Reported Outcomes... Read more
Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year INDIANAPOLIS, June 22, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical... Read more
The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults with type 2 diabetes In ACHIEVE-1, orforglipron also led to an average weight loss of 16.0 lbs (7.9%) at the highest dose by week 40 in a key secondary endpoint The safety profile of orforglipron was consistent with the established GLP-1 class INDIANAPOLIS, June 21, 2025 /PRNewswire/ -- Eli Lilly and Company... Read more
Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA Results from the phase 3b STEP UP trial showed that a higher dose of Wegovy® (semaglutide 7.2 mg) delivered 21% weight loss in people with obesity, with a third of participants losing 25% or more of their weight, compared to placebo1 Safety and tolerability of the higher dose of Wegovy® (semaglutide... Read more
VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP Approval based on ADHERE clinical trial, the largest study of CIDP patients to date First novel mechanism of action for CIDP treatment in more than 30 years Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from... Read more
Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP BP is a chronic, debilitating and relapsing rare skin disease affecting approximately 27,000 adults in the U.S. whose disease is uncontrolled by systemic corticosteroids Dupixent is now approved in the U.S. to treat eight distinct diseases with underlying type 2 inflammation, including diseases... Read more
Pivotal Phase III SUNMO study demonstrated an 11.5 month median progression-free survival – three times longer than R-GemOx This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community care Results will be submitted to global health authorities including the U.S. Food and Drug Administration SOUTH SAN FRANCISCO, Calif. / Jun 20, 2025 / Business Wire / Genentech, a member of the Roche Group (SIX:... Read more
Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide is the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with follicular lymphoma (FL) Patients with relapsed or refractory FL achieved significantly improved progression-free survival with Monjuvi in combination with rituximab and lenalidomide in the Phase 3 registration trial This milestone represents the second approved indication for Monjuvi in the United... Read more
Approval Based on Phase 3 PURPOSE 1 and PURPOSE 2 Data that Showed ≥99.9% of Participants Remained HIV Negative on Twice-Yearly Injectable Yeztugo Yeztugo, Nearly 20 Years in the Making, Represents a Major Breakthrough in the Fight Against HIV FOSTER CITY, Calif. / Jun 18, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company’s injectable HIV-1... Read more
Global Phase 3 BRAVE study will evaluate the efficacy and safety of omaveloxolone in children 2 to <16 years old with Friedreich ataxia, a rare neurodegenerative disorder BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population Omaveloxolone is currently marketed under the brand name SKYCLARYS® for the treatment of adults and adolescents aged 16 years and older affected by Friedreich ataxia... Read more
TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month1 Atogepant met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority... Read more
