The GCAptAIN study did not meet its primary endpoint of sustained remission at Week 52 in adults with newly diagnosed or relapsing GCA1Safety in GCA patients was consistent with known safety profile of Cosentyx® (secukinumab)1EAST 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...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...Read more
JERSEY CITY, N.J. / Jul 02, 2025 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, which Organon acquired through its acquisition...Read more
Starting July 1, 2025, additional opioid overdose response tools will be available to continue addressing evolving patient and customer needs to combat public health crisis GAITHERSBURG, Md., July 02, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced the expansion of its proprietary NARCANDirect® online distribution network to include KLOXXADO® (naloxone HCl) Nasal Spray 8 mg. The platform...Read more
Vascepa is now available to more than 95% of Canadians who are eligible and covered by a public plan or private insurance TORONTO, July 2, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focusing on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that it has entered into a Product Listing Agreement ("PLA") with the province of Nova...Read more
Offer of US$3.01 in cash plus one contingent value right for potential additional aggregate payments of up to US$1.19 per share Upfront and total potential cash consideration represent respectively a 126% and 216% premium to Nasdaq closing price on date prior to announcement of Future Pak’s initial non-binding proposal Transaction with Future Pak represents culmination of sale process whereby Theratechnologies solicited interest from...Read more
FORT LAUDERDALE, FL / ACCESS Newswire / July 2, 2025 / 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 its wholly owned Canadian subsidiary, Nora Pharma Inc., has launched NIOPEG®, the Company's first Biosimilar drug on the market. NIOPEG® is a Biosimilar comparable to the...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...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...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...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...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...Read more
Approval based on Phase III SACHI Trial results which showed a 66% reduced risk of progression or death as compared to platinum-based chemotherapy The only all-oral combination treatment option for these patients Consistent benefit regardless of first-line EGFR inhibitor therapy HONG KONG, SHANGHAI and FLORHAM PARK, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”)...Read more
PWR delivers science-driven cellular energy and recovery support as part of Jupiter’s expanding longevity supplement portfolio Jupiter, Florida, June 30, 2025 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ: JUNS) ("Jupiter" or the "Company"), a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based platform, is pleased to unveil Nugevia™ PWR, a daily mitochondrial health supplement...Read more
Oral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss MIAMI, FLORIDA / ACCESS Newswire / June 30, 2025 / MIRA (NASDAQ:MIRA) today announced new animal study results from SKNY-1, a next-generation oral therapeutic under definitive agreement for acquisition. In a zebrafish model that mimics human obesity and craving behaviors, SKNY-1 demonstrated weight...Read more
New analyses from DEVOTE Part C further characterize the improvements in motor function in participants with SMA who transitioned to the investigational higher dose regimen of nusinersen from 12 mg SPINRAZA® (nusinersen) Final results from the landmark NURTURE study highlight the profound impact of early treatment with 12 mg SPINRAZA in clinically presymptomatic SMA with 92% of children achieving the ability to walk...Read more
GLO targets the growing ”beauty-from-within” market with scientifically proven cellular defense and skin vitality benefits Jupiter, Florida, June 27, 2025 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ: JUNS) ("Jupiter" or the "Company"), a clinical-stage pharmaceutical company developing JOTROL™, a proprietary resveratrol-based platform, is pleased to unveil Nugevia™ GLO—a pioneering "beauty-from-within" supplement designed...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...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...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...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 /...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...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...Read more
OSAKA, Japan & CAMBRIDGE, Mass. / Jun 25, 2025 / Business Wire / Takeda (TOKYO:4502/NYSE:TAK) has announced new assignments of directors, determined at the Board of Directors meeting, following the 149th Annual Meeting of Shareholders, held in Osaka today. Takeda's Board of Directors has 11 members serving as external directors out of a total of 14 members, helping to ensure transparency and objectivity. An external director will...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...Read more
Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safety...Read more
Fiscal year 2025 revenue of $108.3 million, record net income of $2.2 million, operating income of $8.2 million, and record Adjusted EBITDA* of $20.2 million US commercial launch of GRAFAPEX™ executed in February 2025, following swiftly on the FDA's approval in January 2025, with initial indicators supporting Medexus's confidence in the product's potential Management to host conference call at 8:00 AM Eastern time on Thursday, June...Read more
MIAMI, FL / ACCESS Newswire / June 25, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new in vitro preclinical data generated by Eurofins supporting the therapeutic potential of SKNY-1, a next-generation oral drug candidate being developed by SKNY...Read more
NURTuRE-AKI is a novel observational study that collects longitudinal data and biological samples from fully consented acute kidney injury ("AKI") patients, developed as part of a research consortium led by Kidney Research UK The study focuses on 3 clearly defined cohorts: AKI of iatrogenic origin (following cardiac surgery), AKI to chronic kidney disease ("CKD") transition and pediatric AKI. This partnership will enable...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...Read more
RAHWAY, N.J. / Jun 24, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that scientific and commercial team leaders will host a virtual investor event where they will give an overview of the company’s advancing HIV treatment and prevention research pipeline on July 17, 2025, at 9:00 a.m. ET. Investors, analysts, members of the media and the general public are invited to listen...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,...Read more
During the Maintenance Period of 12 weeks after discontinuing semaglutide (GLP-1 receptor agonist), placebo group regained 43% of body weight that was previously lost during Phase 2b QUALITY study; on average, enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo The enobosarm treated groups showed up to 93% greater fat loss and 100% lean mass preservation compared to the...Read more
GAITHERSBURG, Md., June 24, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced that it closed its previously announced private placement pursuant to a securities purchase agreement with an accredited...Read more
CHICAGO, June 24, 2025 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the “Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today its entry into the U.S. market and the launch of U.S.-based...Read more
Intellectual Property Portfolio grows to 221 Patents and 140 Trademarks ANN ARBOR, MI / ACCESS Newswire / June 24, 2025 / Zomedica Corp. (OTCQB:ZOMDF) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced the issuance of a new patent related to its TRUVIEW microscope and provided an update on the Company's current...Read more
The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG IMAAVY, an FcRn blocker, received U.S. FDA approval earlier this year for the broadest population of individuals living with gMG, including anti-AChR and anti-MuSK antibody positive adults and pediatric gMG...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...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...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...Read more
Final analysis of PEARL real world migraine prevention study presented at 11th Congress of the European Academy of Neurology (EAN 2025) Congress in Helsinki1,2 Fremanezumab demonstrated sustained effectiveness and a favourable safety and tolerability profile over the two-year study period1,2 Injection adherence remained high throughout the study (~90%), while over 75% of patients completed the study duration1 TEL AVIV, Israel, June...Read more
MELBOURNE, Australia and INDIANAPOLIS, June 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting. The...Read more
Broad label inclusive of all ages and disease severities Launch to be initiated in Germany WARREN, N.J., June 23, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Sephience™ (sepiapterin) was granted marketing authorization by the European Commission for the treatment of children and adults living with phenylketonuria (PKU). The authorization includes a broad label inclusive of all ages and...Read more
GAITHERSBURG, Md., June 23, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has been awarded a $62.4 million contract modification from the Administration for Strategic Preparedness and Response (ASPR), a division of the United States Department of Health and Human Services (HHS) for BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)]. The modification has been made to...Read more
New pharmacokinetic and cardiac biomarker data further demonstrate ifetroban's potential to protect the heart and reduce cardiac damage in DMD patients NASHVILLE, Tenn., June 23, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company committed to developing new products for rare diseases, shared the latest positive results from its Phase 2 FIGHT DMD trial evaluating ifetroban, a...Read more
Calgary, Alberta – TheNewswire - June 23, 2025 – Voyageur Pharmaceuticals Ltd. (TSXV:VM) (“Voyageur” or the “Company”), a Canadian public company developing cost-effective imaging contrast media, is pleased to announce the signing of a non-binding Memorandum of Understanding (MOU) with U.S. based Altillion Inc., a leading technology innovator in mineral extraction. The collaboration marks the launch of Phase 1 in Voyageur’s plan to develop...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,...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...Read more
Data presented simultaneously at the American Diabetes Association’s® 85th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions1 When adhering to treatment, weight loss of ≥5%, ≥20%, ≥25%, and ≥30% was observed in 97.6%, 60.2%, 40.4% and 23.1% of patients respectively at 68 weeks1* The REDEFINE clinical programme is ongoing to further investigate...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...Read more
Subcutaneous amycretin phase 1b/2a data on the safety, tolerability and weight loss potential in people with overweight or obesity was published in The Lancet and presented at the American Diabetes Association (ADA) Scientific Sessions.1,2 Oral amycretin phase 1 data on the safety, tolerability and weight loss potential in people with overweight or obesity was also published in The Lancet.3 Findings from the clinical...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...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,...Read more
MELBOURNE, Australia and INDIANAPOLIS, June 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces it has launched a novel PET1 radiochemistry solution based on 18F-aluminium fluoride (AlF), named AlFluor™. The AlFluor™ platform technology enables flexible radiolabeling of PSMA2 with either AlF or gallium-68 (68Ga). It also has the potential to be used with ligands...Read more
Emrosi™ (DFD-29; 40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) demonstrated efficacy independent of body weight differences when treating rosacea SCOTTSDALE, Ariz., June 20, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company that primarily focuses on selling...Read more
MELBOURNE, Australia and INDIANAPOLIS, June 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces five abstract presentations and two satellite symposia featuring its developmental theranostic programs and commercial products at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2025 Annual Meeting being held in New Orleans, Louisiana (U.S.) from June 21 –...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...Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / Jun 18, 2025 / Business Wire / The first patient has been dosed in the IDeate-Prostate01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor. Ifinatamab deruxtecan is a...Read more
MariTide is the First Monthly or Less Frequently Dosed Peptide-Antibody Conjugate Being Investigated for the Treatment of Obesity and Type 2 Diabetes New Repatha® Data Provide Insight Into the Benefits of Lipid Lowering Therapy in People With Type 1 Diabetes Amgen to Host Investor Webcast on MariTide Data on June 23 at 4:30 p.m. CDT THOUSAND OAKS, Calif., June 18, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today...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...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...Read more
MIAMI, FL / ACCESS Newswire / June 18, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that the first manuscript describing its lead drug candidate Ketamir-2, currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, has been accepted for...Read more
Top-line results expected July 2025 as development of first-in-class OSA drug advances NEW YORK and MELBOURNE, Australia, June 18, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, is pleased to announce that it has achieved database lock for the RePOSA Phase 2 clinical trial of...Read more
Verve's leading programs aim to deliver lifelong cardiovascular risk reduction with a single dose by targeting genes strongly linked to cardiovascular disease Lilly's established capabilities in cardiometabolic disease and genetic medicines are highly complementary to Verve's vision and expertise INDIANAPOLIS, June 17, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Verve Therapeutics, Inc. (Nasdaq: VERV), a...Read more
Represents Continuation of Long-Running Partnership Focused on Supporting Advancement of Novel Ophthalmic Therapeutic Toward Commercialization CHASKA, Minn., June 17, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced that it has signed a new 10-year commercial manufacturing and supply agreement with a key...Read more
BE-Smart represents a significant advance in diagnosis and management of Esophageal disease that affects an estimated 60 million people in the United States Study shows >95% success rate, validating BE-Smart for use with esophageal brush cytology. UNIONDALE, NY, June 17, 2025 (GLOBE NEWSWIRE) -- ProPhase Labs Inc. (NASDAQ: PRPH), (the “Company” or “ProPhase”) a next generation biotech, genomics and consumer products company,...Read more
New subsidiary, Cynaptec Pharmaceuticals, established to hold global rights to Conjugated Psilocin™ $6 million investment in Cynaptec Pharmaceuticals secured to advance research and early-stage clinical trials for chronic cluster headaches and addiction Option for an additional $20 million investment in Cynaptec Pharmaceuticals to support Phase 3 clinical development VANCOUVER, BRITISH COLUMBIA / ACCESS Newswire / June...Read more
Revenues increased 9% in Q4 2025 compared to Q4 2024, and 12% in FY 2025 compared to FY 2024 Net loss improved 27% in Q4 2025 compared to Q4 2024, and 29% in FY 2025 compared to FY 2024 EBITDA loss improved 59% in Q4 2025 compared to Q4 2024, and 17% in FY 2025 compared to FY 2024 BOULDER, CO / ACCESS Newswire / June 17, 2025 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA),a global healthcare leader developing and...Read more
Expanded platform improves access, scales operations, and advances Incannex’s position in next-generation mental health treatment NEW YORK and MELBOURNE, Australia, June 17, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces entering into a 50:50 joint venture with Mind...Read more
With the addition of 12.5 mg and 15 mg vials, all approved doses of Zepbound will be available in single-dose vials for $499/month or less, regardless of insurance status, under Zepbound Self Pay Journey Program In a clinical trial, adults with obesity or overweight and a weight-related medical condition taking Zepbound 15 mg lost 48 lbs (~21% weight loss) and approximately 1 in 3 on Zepbound 15 mg lost over 58 lbs (25% weight...Read more
NORTH CHICAGO, Ill., June 16, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the global Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of overall survival (OS) with a hazard ratio (HR) of 0.908; stratified log-rank, p=0.3772. No new safety signals were observed.1 Results from the VERONA trial...Read more
Results from Phase IIb PADOVA and longer term follow-up data suggest clinical benefit on top of symptomatic treatment in early-stage Parkinson’s disease Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression Parkinson's disease affects over 10 million people globally and significant unmet need remains SOUTH SAN FRANCISCO,...Read more
95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with lisocabtagene maraleucel (liso-cel) achieved a response, with 62.1% achieving complete response and 88.6% maintaining a response at 24 months New data show liso-cel demonstrated high rates of durable responses and a consistent safety profile in a fifth cancer type, the most of any CD19-directed CAR T cell therapy Additional liso-cel data at ICML 2025...Read more
Teva-engineered TEV-56278 is an anti-PD1-IL2 ATTENUKINE™ therapy in Phase 1 for the treatment of various forms of cancer, including melanoma Fosun Pharma-Teva collaboration agreement established with goal of accelerating clinical data generation for TEV-56278 Partnership leverages strategic relationships to enable research and development of innovative treatments to advance Teva's Pivot to Growth strategy TEL AVIV, Israel and...Read more
Proposed acquisition expected to accelerate mid- to long-term revenue and cash flow growth and further diversify revenue base. Strengthens Supernus’ leading presence in neuropsychiatric conditions with an innovative commercial product, ZURZUVAE® (zuranolone), and a novel CNS discovery platform. Expected to be significantly accretive in 2026 with potential cost synergies of up to $200 million on an annual basis. Upfront cash payment...Read more
Northvale, New Jersey--(Newsfile Corp. - June 16, 2025) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today reported positive results from a pivotal bioequivalence study for an undisclosed anticoagulant generic drug product. IQVIA reported branded product sales for the twelve months...Read more
Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs MILAN, June 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today new results from the Phase 2 RedirecTT-1 study evaluating the...Read more
Phase 1b study suggests a promising safety profile and highlights the potential of a novel dual-targeting CD19/CD20 CAR T in patients with relapsed or refractory disease 75-80% complete response rate among evaluable patients at the recommended Phase 2 dose MILAN, June 13, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the first clinical data from an ongoing Phase 1b study for JNJ-90014496...Read more
Approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1) RAHWAY, N.J. / Jun 13, 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® (pembrolizumab), Merck’s anti-PD-1...Read more
Bleximenib, an investigational selective menin inhibitor, shows potential as combination therapy for the treatment of relapsed or refractory AML and newly diagnosed, intensive chemo-ineligible AML Phase 1b data show low rate of differentiation syndrome and no cardiac safety signal of QTc prolongation MILAN, June 12, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new Phase 1b data showing...Read more
Bagsværd, Denmark, 12 June 2025 – Novo Nordisk today announced that it will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies. The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management. “We are very...Read more
If Approved, NUMELVI Will Be the First and Only Second-Generation Janus Kinase (JAK) Inhibitor for the Treatment of Pruritus Associated with Allergic Dermatitis Including Atopic Dermatitis and Treatment of Clinical Manifestations of Atopic Dermatitis in Dogs RAHWAY, N.J. / Jun 12, 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,...Read more
MOBILIZE-1 is the first Phase 3 study being initiated for V181 as part of a planned robust clinical development program Study will evaluate a single dose of V181 for the prevention of dengue disease caused by any of the four serotypes of the dengue virus regardless of previous exposure RAHWAY, N.J. / Jun 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation...Read more
Innovative Agents Highlight Growth of Targeted Protein Degradation Platform and BMS' Leadership in Innovative Cancer Therapies PRINCETON, N.J. / Jun 12, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the presentation of new data from its targeted protein degradation platform during the 2025 European Hematology Association (EHA) Annual Congress being held from June 12-15 in Milan, Italy. Presentations feature...Read more
Dapirolizumab pegol (DZP) showed efficacy across multiple clinical endpoints in the PHOENYCS GO study, including fatigue and measures of disease activity DZP showed consistent improvements in fatigue, a common and debilitating symptom of systemic lupus erythematosus (SLE) At Week 48, more individuals receiving DZP experienced no or low disease activity compared to standard of care with differences observed as early as Week...Read more
Company expects approval and product supply in market before the end of third quarter GREENFIELD, Ind., June 12, 2025 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) announced today that Zenrelia™ (ilunocitinib) has been granted a positive opinion by the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP), paving the way for the product's marketing authorization in the European Union in...Read more
Key complex product approval in the Affordable Medicines segment this year Commercial launch planned for third quarter of 2025 BRIDGEWATER, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte®. Pred Forte and its design are trademarks...Read more
The Use of Purified Cortrophin® Gel in Murine Collagen-Induced Arthritis Mouse Model presented as a poster at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress PRINCETON, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced new preclinical data on the use of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) in a...Read more
TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo in the Phase 3b APEX study More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24 Improvement in both joint and skin symptoms reinforce TREMFYA® as a first-line treatment option with a proven safety profile for adults with active psoriatic arthritis BARCELONA, June 11,...Read more
MAVYRET® (glecaprevir/pibrentasvir) is the first and only oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV)* With this approval, providers can now treat HCV patients immediately at the time of diagnosis HCV is a curable condition, but patients can often go undiagnosed.1 If left untreated, people with acute HCV could progress to chronic disease, including liver-related...Read more
| Company | Change | Last Trade |
|---|---|---|
| Amgen | 6.33 2.18 | $296.85 |
| Eli Lilly | 3.38 0.44 | $779.28 |
| Biogen | 3.17 2.44 | $133.19 |
| ANI Pharmaceuticals | 1.66 2.61 | $65.22 |
| Phibro Animal Health | 1.32 4.96 | $27.94 |
| AbbVie | 0.76 0.40 | $190.75 |
| Indivior | 0.74 5.05 | $15.40 |
| Novartis | 0.71 0.58 | $123.81 |
| Merck | 0.58 0.71 | $82.39 |
| PTC Therapeutics | 0.56 1.15 | $49.15 |
| Emergent BioSolutions | 0.51 7.73 | $7.11 |
| Telix Pharmaceuticals | 0.42 2.61 | $16.50 |
| Teva Pharmaceutical | 0.41 2.46 | $17.05 |
| Bausch Health | 0.33 4.86 | $7.12 |
| Elanco Animal Health | 0.29 2.01 | $14.72 |
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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Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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