Following Priority Review, the U.S. FDA granted HYRNUO® (sevabertinib) approval for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. WHIPPANY, N.J. / Nov 20, 2025 / Business Wire / Bayer announced today that the U.S. Food and Drug Administration... Read more
New lecanemab findings highlight the safety and potential benefits of subcutaneous administration for initiation dosing, the potential for additional long-term clinical benefits with continued treatment, and real-world experience
Biogen is committed to deepening scientific understanding of Alzheimer’s disease, including therapeutic delivery and disease progression CAMBRIDGE, Mass., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced... Read more
KIRKLAND, QC, Nov. 20, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that it has successfully completed negotiations with the pan‑Canadian Pharmaceutical Alliance (pCPA) for WINREVAIR® (sotatercept). The pCPA negotiates on behalf of the provinces, territories, and federal drug programs serving as a critical step in bringing WINREVAIR® closer to public reimbursement.
WINREVAIR® is indicated in combination with... Read more
SAN DIEGO, Nov. 20, 2025 /PRNewswire/ -- Aspen Neuroscience, Inc., a clinical-stage biotechnology company pioneering autologous regenerative therapies, today announced the closing of a $115 million Series C financing round. This significant investment will fuel the continued clinical development of Aspen's lead program, ANPD001, for moderate to advanced Parkinson's disease.
The Series C round was co-led by OrbiMed, ARCH Venture Partners, Frazier Life Sciences, and... Read more
MISSISSAUGA, Ontario, Nov. 20, 2025 (GLOBE NEWSWIRE) -- BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the three months (Q3) and nine months (YTD) ended September 30, 2025. Key highlights include: (CAD)
Q3 2025
% Change vs.Q3 2024
YTD 2025
% Change vs.YTD 2024
Trailing Twelve Months (TTM) Sept 30, 2025
% Change vs.TTM Sept 30, 2024 Canadian Pharma Sales
9,864,254
+19%
28,351,130
+16%
36,897,581
+14%... Read more
Global Confirmatory Phase 3 DeLLphi-304 Trial Showed IMDELLTRA Reduced Risk of Death by 40% Compared to Chemotherapy
Underscores IMDELLTRA as a Recognized Standard of Care Treatment for Patients With Extensive Stage Small Cell Lung Cancer That Has Progressed THOUSAND OAKS, Calif., Nov. 19, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment... Read more
MELBOURNE, Australia and INDIANAPOLIS, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces results from the ZIRCON-X study which finds that almost half of all patients imaged with TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab) PET/CT2 would have undergone a change in clinical management, when compared with baseline standard of care (SOC) imaging. The data will be presented at the 26th Annual Meeting of the... Read more
PARSIPPANY, N.J. / Nov 19, 2025 / Business Wire / Zoetis Inc. (NYSE:ZTS) will host an Innovation Webcast at 8:30 a.m. ET on Tuesday, December 2, 2025, featuring Kristin Peck, Chief Executive Officer; Wetteny Joseph, Executive Vice President and Chief Financial Officer; Rob Polzer, Ph.D., Executive Vice President and President of Research and Development; and Kevin Esch, D.V.M, M.P.H., Ph.D., Dipl. ACVP (anatomic), Senior Vice President of Global Therapeutics. As previously... Read more
First cohort features 7 real-world challenges across R&D, manufacturing and supply chain, commercial and medical affairs
Teva's first-ever global innovation platform aims to accelerate patient impact and drive business transformation, as part of its Pivot to Growth Strategy
Rise will enable startups and tech players worldwide to validate their solutions in real-world settings, scaling impact across Teva's global ecosystem including in the U.S., Europe, Israel... Read more
Investigational DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority to BIC/FTC/TAF in a Phase 3 clinical trial in treatment-naïve adults with HIV-1 infection
RAHWAY, N.J. / Nov 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from the pivotal double-blind Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir... Read more
This marks the approval of the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered by a health care provider in as little as one minute RAHWAY, N.J. / Nov 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved a new subcutaneous (SC), or under the skin, route of administration and a new pharmaceutical form (solution for injection)... Read more
ProPhase Labs in discussions for strategic initiative to realize significant underlying value in the Company. Voting for Current Proxy Critically Important.
Crown Medical Achieves Final Hurdle. Appointed Special Counsel to Launch Litigation Against Insurance Companies. First Settlement Completed. Reiterates $50 MILLION Net A/R Goal
Next-Phase Commercialization of BE-Smart™ Underway Following Landmark Study Published in the Official Journal of the American College... Read more
WINNIPEG, MB / ACCESS Newswire / November 19, 2025 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today reported its results from operations for the quarter ended September 30, 2025.
Quarter Ended September 30, 2025 Highlights: Recorded total net revenue of $8.2 million during the quarter... Read more
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapyIn the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2 with approximately 3 out of 4 patients achieving a complete r... Read more
UNIONDALE, NY, Nov. 18, 2025 (GLOBE NEWSWIRE) -- ProPhase Labs Inc. (NASDAQ: PRPH) (the “Company” or “ProPhase”), a next generation biotech, genomics and consumer products company, announced today that they will be presenting third quarter 2025 financial results on a virtual conference call hosted by Renmark Financial on November 19, 2025, at 2:00 pm EST.
A press release detailing these results will be issued prior to the virtual conference call. ProPhase Labs... Read more
WINREVAIR demonstrated a statistically significant and clinically meaningful reduction in the primary endpoint of pulmonary vascular resistance (PVR) compared to placebo, improving the ability of blood to transition through the lungs to the heart
These data support proof-of-concept to inform Phase 3 development for WINREVAIR in this population RAHWAY, N.J. / Nov 18, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today... Read more
Arrivals of the twice-yearly PrEP option in Eswatini and Zambia mark an important milestone in the goal of ending the HIV epidemic in sub-Saharan Africa FOSTER CITY, Calif. & MBABANE, Eswatini / Nov 18, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced the delivery of first shipments of lenacapavir – Gilead’s twice-yearly injectable HIV-1 capsid inhibitor – for the prevention of HIV as pre-exposure prophylaxis (PrEP) to Eswatini and... Read more
WIXOM, Mich. / Nov 18, 2025 / Business Wire / Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that the Company appointed Joe Dawson to its board of directors. Additionally, Andrea Heslin Smiley has resigned from the Company's board of directors to pursue other endeavors.
"We are pleased to welcome Joe... Read more
At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy
These unprecedented results support its potential as a new standard-of-care endocrine therapy in the early-stage setting
Data to be presented at an upcoming medical meeting and shared with health authorities around the world
lidERA is the second positive Phase III readout for giredestrant following evERA presented... Read more
Total revenue increased 13% year-over-year to $60.2 million, and adjusted EBITDA rose 20% to $5.1 million.
Telehealth revenue grew 18% to $47.3 million, while telehealth adjusted EBITDA increased 30% to $2.9 million.
Paid off all outstanding debt during the quarter.
Subsequent to quarter end, fully divested our majority stake in WorkSimpli, positioning LifeMD as a pure-play telehealth and pharmacy platform.
Continued to diversify clinical platform with new launches... Read more
Five-year grant of $7 million annually to the academic researchers is aimed at accelerating the development of new therapeutics to combat resistant fungal infections, including the Company’s next generation of triterpenoid antifungals (fungerps).
Next-generation fungerps, in preclinical stages of development, are targeted to have enhanced pharmacological properties to treat fungal infections where current therapies are limited or not effective, while maintaining broad... Read more
CHICAGO, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today reported financial results for the third quarter and nine-month period ended September 30, 2025.
Financial Highlights for the Three and Nine Months Ended September 30, 2025
Income Statement
Cosmos Health delivered a record quarter, achieving the highest revenue, gross profit, and gross... Read more
First-line treatment with TREMFYA® shows significant inhibition of radiographic progression at Week 24, which was sustained through Week 48, preserving joint health with a well-established safety profile
More than half of TREMFYA®-treated patients across both dose groups achieved a 50% improvement in signs and symptoms of psoriatic arthritis by Week 48 in the Phase 3b APEX study NEW YORK, Nov. 17, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:... Read more
LifeMD expands access to Wegovy and Ozempic at the lowest cash-pay pricing, reinforcing its commitment to patient affordability and high-quality care NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) -- LifeMD, Inc. (Nasdaq: LFMD), a leading provider of virtual primary care services and pharmacy, today announced a new, lower cash-pay price for GLP-1 medications, Wegovy® and Ozempic®, made possible through its ongoing collaboration with Novo Nordisk. LifeMD will now offer... Read more
Acquisition provides highly differentiated clinical-stage treatment for prostate cancer, building on Johnson & Johnson’s nearly two decades of innovation in the disease area
Lead asset shows potential to overcome common types of resistance to treatment in prostate cancer with a precision tumor cell-killing approach
Includes novel technology platform capable of developing the next generation of highly targeted oral treatments for multiple solid tumors, including... Read more
Despite treatment with standard-of-care anti-seizure medicines, children with Dravet syndrome experienced high seizure burden and plateaued in neurodevelopment, resulting in a widening gap relative to children with typical development
Findings underscore the urgent need for new medicines that target the underlying genetic cause of Dravet syndrome to improve long-term outcomes CAMBRIDGE, Mass. and BEDFORD, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Biogen... Read more
LUPRON DEPOT (leuprolide acetate for extended-release injectable suspension) is a hormonal medication first approved by Health Canada in 1989 for advanced prostate cancer, and later for various conditions including endometriosis, uterine fibroids, and central precocious puberty.1 MONTREAL, Nov. 17, 2025 /CNW/ - AbbVie (NYSE: ABBV) announced today that a new 6-month 45mg LUPRON DEPOT® (leuprolide acetate for extended-release injectable suspension) strength has received... Read more
Positive CHMP opinion is based on data from the DEVOTE study which evaluated the high dose regimen of nusinersen in treatment-naive participants and those transitioning from the currently approved 12mg dose regimen1
Final European Commission decision expected in January 2026
SMA is a rare, genetic, neuromuscular disease that affects individuals of all ages2 CAMBRIDGE, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the Committee... Read more
SHANGHAI & JERSEY CITY, N.J. / Nov 17, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to PERJETA (pertuzumab), for all indications of the reference product.1 POHERDY is the first and only approved pertuzumab... Read more
PARSIPPANY, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Embecta Corp. (“embecta”) (Nasdaq: EMBC), a global company that is advancing its 100-year legacy in insulin delivery to become a broad-based medical supplies company, today announced that David J. Albritton, a member of the Board of Directors (the “Board”) of embecta, has resigned from the Board due to personal reasons, effective immediately. In addition, LTG (Ret.) David F. Melcher, Non-Executive Chairman of the... Read more
Conference Call Scheduled for Monday, November 17 at 11:30 AM EST Northvale, New Jersey--(Newsfile Corp. - November 14, 2025) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, announced results for the second quarter of fiscal year 2026 ended September 30, 2025 ("Second Quarter").
Consolidated revenues for the three-month period ending September 30, 2025, were $36.3 million,... Read more
CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Alcyone Therapeutics, a clinical-stage biotechnology company known for its innovative CNS therapy delivery solutions, such as the ThecaFlex DRx™ drug delivery system.
ThecaFlex DRx™ is an investigational implantable device designed to provide an alternative to repeat lumbar punctures in chronic intrathecal administration of medicines, which could ease both... Read more
CD388 is an investigational long-acting, strain-agnostic antiviral agent currently in Phase 3, designed to prevent influenza infection in individuals at higher risk of influenza complications
Acquisition aligns with Merck’s science-led business development strategy, diversifying and expanding the company’s pipeline RAHWAY, N.J. & SAN DIEGO, Calif. / Nov 14, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Cidara... Read more
First-to-market complex injectable with expected launch in Q1 2026 BRIDGEWATER, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque® (iohexol) injection. Amneal expects to launch the product in the first quarter of... Read more
Acquisition brings highly differentiated clinical-stage obesity candidates with potential to reshape the treatment landscape
Complements and transforms Pfizer’s Internal Medicine portfolio
Positions Pfizer to lead in one of the most dynamic and high-growth therapeutic areas NEW YORK / Nov 13, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced the successful completion of its acquisition of Metsera, Inc. (NASDAQ: MTSR), a clinical-stage biopharmaceutical... Read more
The Novel HIV Therapy has the Potential to Expand Options for Virologically Suppressed Adults Treated with Complex ART Regimens
Phase 3 Results from ARTISTRY-1 and 2 Trials will Form the Basis of Regulatory Submissions FOSTER CITY, Calif. / Nov 13, 2025 / Business Wire / Gilead Sciences, Inc. (NASDAQ: GILD) today announced positive topline results from the Phase 3 ARTISTRY-1 trial. The open-label trial evaluated the treatment responses of adults with HIV... Read more
Alloy Partners, Elanco and other corporate partners join forces to develop new venture studio INDIANAPOLIS, Nov. 13, 2025 /PRNewswire/ -- Alloy Partners today announced the launch of OneHealth Studio, a first-of-its-kind venture studio designed specifically to create and scale new companies at the convergence of animal, plant and human health in partnership withElanco Animal Health (NYSE: ELAN).
Located in the OneHealth Innovation District at Elanco's new global... Read more
Once issued, this new U.S. patent covers the use of CardiolRx™ and CRD-38 for a broad range of cardiac disorders, including atherosclerosis and heart failure, significantly expanding intellectual property protection in the world's largest pharmaceutical market. This allowance fortifies Cardiol's global intellectual property portfolio, adding to granted and pending patent applications in Europe, Japan, Canada, Australia, and China. Toronto, Ontario--(Newsfile... Read more
Adjusted EBITDA grew 19% in Q3 and 25% year-to-date
Cash from operations grew 67% in Q3 and 121% year-to-date
Announced new credit facility with lower rates, increased flexibility and reduced F/X risk
Bempedoic acid approval expected in Q4 2025; preparations underway for Q2 2026 launch TORONTO, Nov. 13, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the... Read more
Reports Significant Revenue Growth to $590K and Substantial Increase in Gross Profit to $575K
Launched Sales of Arbli™, the First FDA-Approved Ready-To-Use Liquid Formulation of Losartan for Hypertension COMMACK, NY, Nov. 13, 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,... Read more
Entered into an Agreement to be acquired by QOL Medical
Net product sales for the third quarter of 2025 reached $4.3 million; up 61% year-over-year
Gimoti patent life for Gimoti extended through November 2038 SOLANA BEACH, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI® (metoclopramide) nasal spray, today reported... Read more
Conference call will be held today, Thursday, November 13 at 10:00 am ET Woburn, MA, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three and nine months ended September 30, 2025 and provided a business update.
Financial highlights Revenues for the first nine months... Read more
Management to host conference call at 8:00 AM Eastern time on Thursday, November 13, 2025 Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - November 12, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company's second fiscal quarter ended September 30, 2025 (the company's fiscal Q2 2026). All dollar amounts in this press release are in United States dollars... Read more
Third quarter 2025 net revenues were $17.6 million
Emrosi™ total prescriptions increased 146% over the second quarter of 2025
Emrosi net revenues were $4.9 million
Company to hold conference call today at 4:30 p.m. ET to discuss the financial results and provide a business update SCOTTSDALE, Ariz., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical,” “the Company,” “we” or “our”), a commercial-stage... Read more
LONDON, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) today announced that management will present at the Jefferies Global Healthcare Conference in London on Monday, November 17, 2025 at 2:30 p.m. Greenwich Mean Time (9:30 a.m. Eastern Time).
A live webcast of Kiniksa’s presentation will be accessible through the Investors section of the company’s website at www.kiniksa.com. A replay of the event will also be available... Read more
TEL AVIV, Israel, Nov. 12, 2025 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) today announced that DeepSolar, its solar energy business unit developing next-generation AI analytics, has advanced the development of its proprietary automated reporting engine, designed to transform how solar-asset performance is analyzed, understood, and communicated. The automated reporting engine reduces manual effort and produces tailored reports according to the customers’ need... Read more
Positive FDA feedback confirms clear clinical pathway for BX011 targeting S. aureus in Diabetic Foot Infections, building on Company’s prior Phase 2 success
BiomX expects FDA feedback on BX004 clinical hold imminently; Enrollment and dosing of patients outside the U.S. are continuing in accordance with protocol
Positive FDA feedback received in October provided guidance for potential Phase 3 development pathways of BX004
BiomX will host a conference call and... Read more
Northvale, New Jersey--(Newsfile Corp. - November 12, 2025) - Elite Pharmaceuticals, Inc. (OTCBB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP), with strengths of 2 mg, 4 mg, 6 mg, 8 mg, and... Read more
RANCHO CUCAMONGA, CA / ACCESS Newswire / November 12, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, and Jacob Liawatidewi, EVP of Corporate Administration, will be participating in an Analyst-Moderated fireside chat at the Jefferies Global Healthcare Conference on Wednesday, November 19th, 2025, at 3:30 pm GMT. For access, visit Amphastar's Pharmaceuticals website at http://ir.amphastar.com. This webcast will be available for... Read more
Closed $17 million first tranche financing led by a strategic investment from CorMedix, Inc.
Cash and investments at September 30, 2025 were $21.3 million; combined with conditional future tranches of previous financings, expect sufficient cash through a potential PMA approval of Niyad in late 2026
5 of the 9 target profile clinical sites are now activated; completion of NEPHRO study expected in H1 2026
Conference call and webcast to be held Wednesday, November 12,... Read more
