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: RHHBY)announced today that the... 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 LifeMD’s pharmacy growth strategy... 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 definitive agreement to acquire... 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 as-needed albuterol,2 the most commonly... 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 everyday real-life use. It fills a significant... 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 equine and companion animals, today... 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 SURPASS-PEDS, the first Phase 3 trial to... 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 therapy submitted to the US Food... 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 depressive symptoms as early as day 3 and... 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 Lilly and Company (NYSE: LLY) today... 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 standard for treating patients... 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® (anifrolumab) demonstrated a statistically... Read more
The investigational once-daily oral pill led to an average weight loss of 27.3 lbs (12.4%) at the highest dose at week 72 in the Phase 3 study
Orforglipron demonstrated significant improvements across key cardiometabolic risk factors, supporting its potential as a treatment option for millions living with obesity INDIANAPOLIS, Sept. 16, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from the Phase 3 ATTAIN-1 trial, evaluating... Read more
TEL AVIV, Israel, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced plans to present data from the completed phase 3 SOLARIS trial at the 2025 Psych Congress Annual Meeting, taking place from September 17 – 21, 2025, in San Diego, California.
Teva will also host a conference call for analysts and investors on Monday, September 22, 2025, at 11:00 a.m. ET to discuss these data.
In order to participate, please... Read more
New site in Virginia's Goochland County will develop active pharmaceutical ingredients (API) in the U.S. for cancer, autoimmune and other advanced therapies
Company will create 2,450 high-wage manufacturing and construction jobs
This marks the first of four new U.S. manufacturing sites that Lilly plans to announce this year INDIANAPOLIS, Sept. 16, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that it plans to build a $5 billion manufacturing... Read more
All 172 patients have now entered the 12-month follow-up phase
Trial involves larger surface areas, building on the approval in October 2024 for use of up to 3 tubes of Ameluz® per treatment
Study results expected to form the basis of a supplemental New Drug Application (sNDA) planned for submission in Q2 2026 WOBURN, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company s... Read more
The integration of Accu-Chek SmartGuide's AI-enabled predictive CGM with the popular mySugr app delivers a simple, intuitive solution for people to manage their diabetes with greater ease.
Accu-Chek SmartGuide is now available in 13 countries, with plans to accelerate access to over 30 countries across Europe, Latin America and Asia-Pacific by year-end.
Real-world evidence from rollout and clinical perspectives presented at the European Association for the Study of... Read more
Arbli™ is the first and only ready-to-use liquid formulation of losartan, eliminating the need for compounding while offering reduced dosing volume and extended room-temperature shelf life COMMACK, NY, Sept. 16, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization,... Read more
VELA to operate the world’s first sailing cargo trimaran powered by 100 percent wind when at sea1 to sail between Europe and the U.S.
Takeda to become the first biopharmaceutical company to ship its products on VELA’s wind-powered trimaran, starting a new era of sustainable shipping in pharma OSAKA, Japan & CAMBRIDGE, Mass. / Sep 16, 2025 / Business Wire / Takeda (TSE:4502/NYSE:TAK) and VELA Transport today announced their business partnership, with Takeda set... Read more
MIRA advances Ketamir-2 in the clinic for neuropathic pain while broadening development into neuropsychiatric disorders such as PTSD MIAMI, FLORIDA / ACCESS Newswire / September 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced positive results demonstrating that its oral drug candidate Ketamir-2... Read more
Positive results show that the average weight loss was 12.5 kg (11.8% body weight reduction) with cagrilintide compared to 2.5 kg (2.3%) with placebo, after 68 weeks*1,2
Cagrilintide was well-tolerated, with the most common side effects being gastrointestinal; these were mainly transient and mild to moderate in severity1
Based on these results, Novo Nordisk will advance cagrilintide into the dedicated RENEW phase 3 clinical programme later this year Bagsværd, Denmark,... Read more
Results from a real-world survey suggest that semaglutide for weight management (Wegovy®) helped suppress food noise – unwanted and intrusive thoughts about food – in addition to its established effect on weight loss1
The number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy®1
The majority of respondents reported improved mental health (64%) and healthier habits (80%) while... Read more
New data show how Sympazan is being used in daily clinical practice to treat patients with Lennox-Gastaut Syndrome (LGS), a severe form of childhood-onset epilepsy
Study addresses lack of awareness and real-world data with oral film formulation of clobazam
New data presented during poster session at 150th Annual Meeting of the American Neurological Association
SYMPAZAN is the only FDA-approved oral film formulation of clobazam for adjunctive treatment of seizures associated... Read more
GAITHERSBURG, Md., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced it has received a $17 million contract modification from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to supply TEMBEXA® (brincidofovir) oral suspension. This follows the U.S. Food... Read more
Oral semaglutide (Rybelsus®) is now the first and only oral GLP-1 RA approved for type 2 diabetes, with proven cardiovascular benefits1
This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus®) reduced cardiovascular death, heart attack and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk1
In addition, new results from SOUL will be presented at one of the... Read more
21 abstracts from across the Company's portfolio highlight clinical and real-world data on major depressive disorder, treatment-resistant depression and schizophrenia
New Phase 3 data demonstrate the safety and efficacy of adjunctive seltorexant compared to quetiapine XR in major depressive disorder with insomnia symptoms TITUSVILLE, N.J., Sept. 15, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 21 abstracts featuring new real-world and... Read more
First Breakthrough Therapy Designation for Daiichi Sankyo and Merck’s raludotatug deruxtecan based on phase 1 trial and REJOICE-Ovarian01 phase 2/3 trial
Second Breakthrough Therapy Designation since the start of the Daiichi Sankyo and Merck collaboration
Fifteenth Breakthrough Therapy Designation granted by FDA across the oncology portfolio of Daiichi Sankyo BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 15, 2025 / Business Wire / Raludotatug deruxtecan (R-DXd) has... Read more
PARSIPPANY, N.J. / Sep 12, 2025 / Business Wire / Zoetis Inc. today announced that the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of marketing authorization for Portela® (relfovetmab), a new monoclonal antibody (mAb) therapy intended for the alleviation of pain associated with osteoarthritis (OA) in cats.
Portela Will Be First Long-Acting Anti-NGF mAb Therapy for Cats,... Read more
MONTREAL, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that its shareholders have approved the previously announced plan of arrangement (the “Arrangement”) under Chapter XVI – Division II of the Business Corporations Act (Québec) involving CB Biotechnology, LLC (the “Purchaser”),... Read more
SKNY transaction strengthens MIRA pipeline with SKNY-1, a differentiated oral candidate that has demonstrated up to 30% weight loss and nicotine craving reversal in preclinical studies. MIAMI, FL / ACCESS Newswire / September 12, 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 that its... Read more
The transaction adds larsucosterol, an FDA Breakthrough Therapy for alcohol-associated hepatitis with a registrational Phase 3 clinical trial in development, to Bausch Health's hepatology pipeline LAVAL, QC, AND CUPERTINO, CA / ACCESS Newswire / September 11, 2025 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) ("Bausch Health"), a global, diversified pharmaceutical company, today announced the successful completion of its previously announced tender offer to acquire... Read more
Expands Amneal’s Affordable Medicines portfolio and broadens patient access BRIDGEWATER, N.J, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem®. Amneal had previously been distributing an authorized generic... Read more
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Cosmos Health Inc. (“Cosmos Health” or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today announced that its wholly owned subsidiary, Sky Pharm SA, signed a distribution agreement (the “Agreement”) with Scientific Pharmacy LLC (“Scientific Pharmacy”) for its Sky Premium Life food supplement products in Oman.
Scientific Pharmacy, the retail and wholesale... Read more
Results from the Phase 3 STRIDE-13 trial presented at the 6th ESCMID Conference on Vaccines
Merck to share STRIDE-13 results with global regulatory authorities RAHWAY, N.J. / Sep 11, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th European Society of Clinical Microbiology and Infectious... Read more
Rhonda Pacheco to Succeed Julie Kim, Who Was Appointed to Be Takeda’s Next CEO CAMBRIDGE, Mass. / Sep 11, 2025 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that Rhonda Pacheco, most recently group vice president of U.S. Cardiometabolic Health at Eli Lilly, will join Takeda, effective September 29, as president of Takeda’s U.S. Business Unit and will be a member of the Takeda Executive Team. Pacheco will succeed Julie Kim, who was appointed by the... Read more
BEIJING, Sept. 10, 2025 /PRNewswire/ -- Shineco Inc. (NASDAQ: SISI) ("Shineco" or the "Company"), a leading developer of induced pluripotent stem cell (iPSC) technology platforms, today announced that its subsidiary, Fuzhou Meidashan Biotechnology Co., Ltd., has successfully achieved large-scale production of high-purity, highly active free-form soybean phospholipids. This breakthrough was made possible through its proprietary APCC-UF pure physical extraction... Read more
Transformation to increase speed and redirect resources to growth opportunities within diabetes and obesity, aiming at reaching millions of untreated patients
Intention to reduce ~9,000 roles globally with the expectation to deliver DKK 8bn of annualised savings by the end of 2026
One-off restructuring costs of DKK 8bn leading to an updated full-year 2025 operating profit growth outlook of 4–10% at CER Bagsværd, Denmark, 10 September 2025 – Novo Nordisk today... Read more
Poster presentation will feature new data for SYMPAZAN, the only FDA-approved oral film formulation of clobazam for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older
Abstract is now available on ANA2025 website LAKE FOREST, Ill., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities... Read more
Agreement strengthens Canadian veterinarians' access to Zomedica's advanced therapeutic and monitoring solutions ANN ARBOR, MI / ACCESS Newswire / September 10, 2025 / Zomedica Corp. (OTCQB:ZOMDF), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, announced today that it has expanded its distribution agreement with UXR Inc., a leading Canadian animal health company focused on supporting the needs... Read more
VANCOUVER, B.C. / ACCESS Newswire / September 9, 2025 / Lobe Sciences Ltd. ("Lobe" or the "Company") (CSE:LOBE)(OTCQB:LOBEF)(FWB:LOBE.F) a clinical stage biopharmaceutical company focused on developing products to treat diseases with significant unmet medical needs is pleased to announce its participation in the upcoming Clusterbusters 20th Annual U.S. Patient Conference taking place September 11-14, 2025, in Grapevine, Texas (near Dallas/Ft. Worth).
This conference is... Read more
MELBOURNE, Australia and INDIANAPOLIS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis.
BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study1) is the first regi... Read more
First and only drug releasing system to provide extended local delivery of a cancer medication into the bladder, with 82 percent of patients achieving complete response without the need for reinduction1
Potential practice-changing treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer who have limited options before possible bladder removal RARITAN, N.J., Sept. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today... Read more
Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development.
New therapeutic options for people living with MSA, a rare and devastating neurodegenerative disorder, are urgently needed as there are no treatments available that impact disease progression.
Emrusolmin is a small molecule that targets the alpha synuclein protein, which is... Read more
Program provides access to Lilly-trained artificial intelligence to help accelerate breakthrough medicines
New offering expands Lilly Catalyze360's support for early-stage drug development INDIANAPOLIS, Sept. 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the launch of Lilly TuneLab, an artificial intelligence and machine learning (AI/ML) platform that provides biotech companies access to drug discovery models trained on years of Lilly's... Read more
VANCOUVER, BC / ACCESS Newswire / September 8, 2025 / Lobe Sciences Ltd. ("Lobe Sciences" or the "Company") (CSE:LOBE) (OTCQB:LOBEF) (FWB:LOBE.F) a clinical stage biopharmaceutical company focused on developing products to treat diseases with significant unmet medical needs is pleased to announce the appointment of Mr. Marco Mastrodonato to the Company's Board of Directors.
Mr. Mastrodonato brings extensive leadership and international business development experience in... Read more
THOUSAND OAKS, Calif. and TOKYO, Sept. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD).
The ongoing ASCEND study, which includes approximately 2,600 patients, is designed to evaluate... Read more
NEW BRUNSWICK, N.J. / Sep 08, 2025 / Business Wire / Johnson & Johnson (NYSE: JNJ) announced today that John Morikis, retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, has been elected to its Board of Directors.
“We are pleased to welcome John to our Company’s Board of Directors,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “He is a proven leader of a large multinational organization... Read more
Announces Commitment for New $40 Million Revolving Credit Facility
Issues Conditional Notice of Redemption of 11.875% Senior Notes due 2027 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that it has commenced a private offering (the “Offering”) of $250.0 million aggregate principal amount of senior unsecured notes due 2030... Read more
In the Phase 3 BRUIN CLL-313 study, treatment with pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival versus bendamustine plus rituximab, indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study
BRUIN CLL-313 is the third positive Phase 3 study from the pirtobrutinib development program in CLL
Results from BRUIN CLL-313... Read more
Phase 3 clinical trial cohort of adults 65+ and 18-64 with at least one underlying risk condition shows at least a 4-fold increase in LP.8.1-neutralizing antibody titers after receiving the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula
First LP.8.1 sublineage clinical findings reinforce pre-clinical data supporting recent FDA approval of 2025-2026 Formula of Pfizer-BioNTech COVID-19 Vaccine
Companies have submitted these data to the FDA NEW YORK & MAINZ, Germany... Read more
