Investigational T-cell engager, surovatamig, and CAR T-cell therapy, AZD0120, will show potential with initial data across multiple blood cancers New results will showcase benefit of CALQUENCE® in patients with mantle cell lymphoma and chronic lymphocytic leukemia New data will further support clinical benefits of ULTOMIRIS® in paroxysmal nocturnal hemoglobinuria and its potential to improve outcomes for pediatric patients with...Read more
BAY 3401016 is an investigational monoclonal antibody with potential to block a protein called Semaphorin 3A (Sema3A), which is thought to be involved in the progression of kidney damage in Alport Syndrome (AS), a rare genetic disorder Bayer explores opportunity to address high unmet medical need of patients suffering from AS and advances research efforts through close cooperation with AS patient organizations Derived from the strategic...Read more
Newest assay expands TRUFORMA market opportunity by building on endocrinology foundation to address reproductive health in the equine segment ANN ARBOR, MI / ACCESS Newswire / December 4, 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 announced the expansion of its TRUFORMA...Read more
MIAMI, FL, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced multiple presentations at The Society on Sarcopenia, Cachexia, and Wasting Disorders (SCWD) 18th International Conference, and the SCWD’s Regulatory and Clinical Trials Update Regulatory Workshop,...Read more
Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz® over treatment area of 240 cm2 Completion of this study marks a key milestone towards a planned summer 2026 FDA submission for FDA approval for the use of Ameluz® on all non-face and scalp areas WOBURN, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a...Read more
Phase 2 clinical trial initiated to evaluate SEMA3A mAb as potential treatment for Alport syndrome Milestone payment to Evotec expected upon first dosing of first study participant in early 2026 HAMBURG, DE / ACCESS Newswire / December 4, 2025 / Evotec SE (Frankfurt Stock Exchange:EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ:EVO) today announced that its partner Bayer AG has initiated a Phase 2...Read more
Approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL in which all patients were previously treated with a covalent BTK inhibitor This expanded indication represents a substantial increase in the number of CLL/SLL patients who may benefit from Jaypirca and aligns with the patient population endorsed by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) INDIANAPOLIS,...Read more
Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee BMS Remains Blinded to Study Data PRINCETON, N.J. / Dec 03, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY, “BMS”) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2...Read more
Bayer revealed first results of the pediatric study from the pivotal clinical development program QUANTI for its low-dose MRI contrast agent QUANTI Pediatric evaluated the pharmacokinetics and safety of gadoquatrane in children (birth to <18) at a gadolinium dose of 0.04 mmol Gd/kg body weight, representing a dose reduction of 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight Data are part of...Read more
Long-term LEQEMBI treatment suggests potential to delay disease progression from Mild Cognitive Impairment (MCI) to moderate Alzheimer's disease by up to 8.3 years in low-amyloid group who started treatment at an early stage New safety and efficacy data presented at scientific symposium on subcutaneous formulation for LEQEMBI initiation treatment, which is under regulatory review in the United States TOKYO and CAMBRIDGE,...Read more
MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IHL-42X, the Company’s oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea (OSA). The Fast Track...Read more
Data being presented showcases AbbVie's breadth and depth of research across a range of therapeutic modalities such as T-Cell Engagers, BCL-2 Inhibitors and Antibody-Drug Conjugates for a spectrum of difficult-to-treat blood cancers NORTH CHICAGO, Ill., Dec. 2, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will unveil new data at the 2025 American Society of Hematology (ASH) Congress, showcasing continued advances in...Read more
Submission based on positive BaxHTN Phase III trial results which demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension If approved, baxdrostat could be the first aldosterone synthase inhibitor to receive regulatory authorization WILMINGTON, Del. / Dec 02, 2025 / Business Wire / AstraZeneca’s New Drug Application (NDA) for...Read more
Study further expands clinical development program of Bayer’s long-acting reversible intrauterine system Mirena® (levonorgestrel-releasing intrauterine system) 52 mg. Approximately 121 out of every 100,000 women develop nonatypical endometrial hyperplasia (NAEH), a benign form of endometrial thickening, each year.1 Currently, there are no approved medical treatment options for NAEH in the U.S. Mirena is globally available in more than...Read more
TOKYO and CAMBRIDGE, Mass., Dec. 2, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name: LEQEMBI®), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in...Read more
BANGALORE, India / Dec 02, 2025 / Business Wire / Aurigene Oncology Limited, a clinical-stage biopharmaceutical company developing novel therapies in oncology, today announced initial clinical results from 1st two cohorts of its ongoing Phase 1 clinical trial evaluating AUR112 in patients with relapsed or refractory lymphoid malignancies. Early findings show that AUR112 is safe, well tolerated, demonstrating meaningful clinical activity,...Read more
Represents second complex respiratory therapeutic product approval in Q4 2025 BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR® HFA (albuterol sulfate...Read more
BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced that Chirag Patel, Co-Chief Executive and President, and Tasos Konidaris, Chief Financial Officer, will participate in following upcoming investor conferences: Piper Sandler 2025 Healthcare ConferenceDate: December 3, 2025Fireside Chat: Wednesday, December 3, 2025, at 9:30AM ESTLocation: New York, NY J.P. Morgan 2026...Read more
New data published in Pain Physician shows significant improvement in functional outcomes with iovera° Fewer iovera° patients required additional spine injections after 180 days No treatment-related adverse events were reported BRISBANE, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the...Read more
sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025 First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA Primary and key secondary endpoints met with high statistical significance (p <0.0001) Favorable recurrence outcomes at one-year follow-up BCC is the most common skin cancer in the US with more than 3 million cases diagnosed...Read more
Development plan positions OcuRing™-K for advancement in the fast-growing, multi-billion-dollar global cataract surgery market TEL AVIV, Israel, Dec. 02, 2025 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) today announced, through its pharmaceutical division, the commencement of its development plan for OcuRing™-K, LayerBio’s patented, drop-less, intraoperatively administered sustained-release ocular therapy designed to...Read more
Merck granted Fast Track Designation by the U.S. FDA for MK-2214 for the treatment of Alzheimer's disease RAHWAY, N.J. / Dec 01, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer’s Disease (CTAD) 2025 in San Diego, California from Dec. 1-4. In addition, the company announced that...Read more
Iberdomide shows deep and sustained responses in newly diagnosed multiple myeloma First-in-class lymphoma CELMoD™ agent, golcadomide, delivers durable responses in combinations across aggressive and indolent lymphomas First-in-class BCL6 ligand-directed degrader demonstrates promising efficacy and tolerability in relapsed/refractory NHL Long-term Breyanzi data confirm durable benefit and high survival rates in LBCL and FL PRINCETON,...Read more
Centargo compatible with Ultravist® (iopromide), Isovue® (iopamidol), Optiray® (ioversol), Omnipaque™ (iohexol) and now, Visipaque™ (iodixanol) Follows recent FDA clearance to expand the use of compatible contrast agent presentations, adding single-dose vials in addition to Imaging Bulk Package presentations Radiology suites now have the ability to further manage contrast consumption and waste, while providing greater flexibility for...Read more
Approval underscores Amneal’s advanced sterile manufacturing capabilities and expansion within complex ophthalmic therapies; Launch expected in Q1 2026 BRIDGEWATER, N.J., Dec. 01, 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 cyclosporine ophthalmic emulsion 0.05%, a sterile,...Read more
Transaction boosts Solta Medical's position to meet rising demand in China's growing aesthetics market LAVAL, QC / ACCESS Newswire / December 1, 2025 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC), a global, diversified pharmaceutical company, along with its global aesthetic business, Solta Medical, today announced the successful completion of the acquisition of Wuhan Shibo Zhenmei Technology Co., Ltd., consisting of the Shibo...Read more
Patrick D. Walsh steps down as Chairman and will complete his current term as Board member Thomas J. Haughey has been unanimously elected to serve as the next Chairman of the Board PRINCETON, N.J., Dec. 01, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced that its Chairman, Patrick D. Walsh, will retire from the Company's Board of Directors after a distinguished tenure of...Read more
Phase II ARCHER trial showed a significant reduction in left ventricular (LV) mass (p=0.0117) and improvements in multiple key cardiac MRI (CMR) measures of structural heart recovery in patients with acute myocarditis. Results provide clinical evidence that CardiolRx™ reduces inflammation-driven structural damage in the heart, an important cause of heart failure progression. The ARCHER data strengthen the scientific and...Read more
SKYRIZI® (risankizumab), an IL-23 inhibitor, received two consecutive positive reimbursement recommendations by Canada’s Drug Agency (CDA-AMC) for inflammatory bowel diseases, initially for Crohn’s disease (CD) and now for ulcerative colitis (UC), supported by evidence from pivotal phase 3 clinical trials including MOTIVATE, ADVANCE, FORTIFY (for CD), and INSPIRE, COMMAND (for UC).1,2 AbbVie concludes letter of intent (LOI) with the...Read more
Based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of progression, recurrence or death and a 22% reduction in the risk of death for the IMFINZI regimen vs. chemotherapy alone WILMINGTON, Del. / Nov 26, 2025 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for...Read more
PARSIPPANY, N.J. / Nov 26, 2025 / Business Wire / Zoetis Inc. today announced that the European Commission has granted the company marketing authorization for Lenivia® (izenivetmab) for the reduction of pain associated with osteoarthritis (OA) in dogs. Lenivia is a new antibody therapy that reduces OA pain in dogs for three months with one injection through its novel binding properties to nerve growth factor (NGF), recognized as an...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 27, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology (“ESMO”) Asia Congress 2025, taking place on December 5-7, 2025 in Singapore, and the American Society of Hematology (“ASH”) Annual...Read more
Following the positive opinions of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorizations for Teva’s biosimilars PONLIMSI and DEGEVMA expanding access to important bone health treatments across Europe These approvals mark another significant milestone in Teva’s strong biosimilars portfolio, in line with Teva's Pivot to Growth Strategy The approvals underscore Teva’s...Read more
LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start of therapy to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Nov. 25, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts,...Read more
JERSEY CITY, N.J. / Nov 25, 2025 / Business Wire / Organon (NYSE: OGN), announced today that Joe Morrissey, Interim Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3rd, 2025 at 10:00 a.m. ET. Investors, analysts, members of the media and the general public are invited to listen to a live audio...Read more
PRINCETON, N.J., Nov. 25, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, at 2:00 p.m. ET. The live and archived fireside chat will be accessible from the Company’s website at www.anipharmaceuticals.com, under the Investors...Read more
PARSIPPANY, N.J., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Embecta Corp. (“embecta” or the "Company") (Nasdaq: EMBC), a global diabetes care company, today reported financial results for the three- and twelve-month periods ended September 30, 2025. "Our fourth quarter results were largely in line with our expectations, with revenue lower year over year due to several items we had previously anticipated, including the impact of advanced...Read more
The Company continues working with the third-party manufacturer to address recent FDA follow-up information requests which are required to lift the clinical hold concerning the nebulizer device used in the Phase 2b trial An independent Data Monitoring Committee (DMC) completed a safety review following adverse events identified in the BX004 Phase 2b trial and recommended that the study continue with revised dosing Following the DMC...Read more
Results from the BRUIN CLL-314 study comparing Jaypirca (pirtobrutinib) to Imbruvica (ibrutinib) – the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve CLL/SLL patients – will be presented as an oral presentation Results from the Phase 3 BRUIN CLL-313 study of pirtobrutinib in patients with treatment-naïve CLL/SLL will be featured as a late-breaking oral presentation Both BRUIN CLL-314...Read more
Updated results from the Phase 3 EMBER-3 trial for Inluriyo™ (imlunestrant) alone and in combination with Verzenio® (abemaciclib) in ER+, HER2– metastatic breast cancer to be presented as a late-breaking oral presentation Updated safety and efficacy data to be presented from PIKALO-1, the Phase 1/2 trial of Lilly's pan-mutant-selective PI3Kα inhibitor, which will be advanced into the Phase 3 PIKALO-2 study New subgroup analysis from...Read more
NORTH CHICAGO, Ill., Nov. 24, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3, 2025. Management will participate in a fireside chat at 7:30 a.m. Central time. A live audio webcast of the presentation will be accessible through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that...Read more
First presentation for MK-1045, a novel CD19xCD3 T-cell engager in patients with certain types of leukemia and lymphoma, and for bomedemstat, an LSD1 inhibitor, in patients with polycythemia vera New data demonstrate continued progress with nemtabrutinib, an investigational non-covalent BTK inhibitor RAHWAY, N.J. / Nov 24, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced...Read more
THOUSAND OAKS, Calif., Nov. 24, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at Citi's 2025 Global Healthcare Conference at 1:45 p.m. ET on December 3, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development at Amgen, will present at the conference. The webcast will be broadcast over the internet...Read more
THOUSAND OAKS, Calif., Nov. 24, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 8th annual Evercore ISI HealthCONx Conference at 10:00 a.m. ET on December 3, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development at Amgen, will present at the conference. The webcast will be broadcast over the...Read more
PRINCETON, N.J. / Nov 24, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that, following the conclusion of the American Society of Hematology (ASH) Annual Meeting and Exposition, the company will hold a virtual investor event on Thursday, December 11, 2025, to highlight key Hematology programs. The company will host a webcast beginning at 9:00 a.m. ET, which is accessible here. Company representatives will provide...Read more
In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% of patients achieving complete response Breyanzi demonstrated sustained clinical benefit, with 50.8% of patients still in response at 24 months based on TRANSCEND MCL trial results PRINCETON, N.J. / Nov 24, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to Breyanzi®...Read more
Oral macrocyclic peptides have the potential to offer biologic-like efficacy and safety in a convenient oral format Collaboration further advances Biogen’s immunology strategy by broadening its early-stage pipeline and incorporating an additional clinically validated modality into its expanding immunology capabilities CAMBRIDGE, Mass. and TORONTO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Dayra Therapeutics...Read more
NASHVILLE, Tenn., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that management will participate in the following two investor conferences in December: BTIG 5th Annual Ophthalmology Day (Virtual) Format: Fireside chatDate/Time: Monday, December 1, 2025, at 8:30 AM EST Piper Sandler 37th Annual Healthcare Conference (New York,...Read more
RANCHO CUCAMONGA, CA / ACCESS Newswire / November 24, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, and Tony Marrs, EVP of Regulatory Affairs and Clinical Operations, will be participating in an Analyst-Moderated fireside chat at the 37th Annual Piper Sandler Healthcare Conference on Wednesday, December 3rd, 2025, at 2:00 pm ET. For access, visit Amphastar's Pharmaceuticals website at...Read more
OCEANIC-STROKE demonstrates superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor Bayer will globally engage with health authorities in preparation for the submission of marketing authorization...Read more
New capacity at AstraZeneca’s Fredrick and Gaithersburg facilities will accelerate production of cancer, rare and chronic disease medicines Fourth major US manufacturing investment announced this year, advancing AstraZeneca’s historic $50 billion commitment to medicines manufacturing and R&D WILMINGTON, Del. / Nov 21, 2025 / Business Wire / AstraZeneca today announces plans to invest $2 billion to expand its long-standing...Read more
Represents the first PD-1 inhibitor plus ADC regimens for this patient population RAHWAY, N.J. / Nov 21, 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) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev® (enfortumab vedotin-ejfv), as...Read more
PADCEV plus Keytruda is the first and only approved perioperative treatment regimen that can significantly improve survival over current standard of care (surgery alone) in cisplatin-ineligible patients with muscle-invasive bladder cancer Approval is based on unprecedented data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression or death and a 50% reduction in the risk of death...Read more
TEL AVIV, Israel, Nov. 21, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that Richard Francis, Teva's President and CEO, and other members of executive management will present at three upcoming investor conferences in December as follows: 8th Annual Evercore Healthcare ConferenceWednesday, December 3, 2025, at 8:20 A.M. Eastern Time (ET) Piper Sandler 37th Annual Healthcare...Read more
EUA to Treat Cats for NWS Issued Prior to Fly Being Detected in the U.S.; Action Prepares Veterinarians and Pet Owners with Treatment Options First U.S. Food and Drug Administration Emergency Use Authorization (EUA) granted for New World screwworm in cats, reinforcing Elanco's leadership in feline innovation Action reinforces the FDA's commitment to act swiftly against emerging animal health threats Scientific studies...Read more
Rockville, Maryland--(Newsfile Corp. - November 21, 2025) - Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ: SHPH) ("Shuttle" or the "Company") today announced that it has closed the acquisition of the assets and liabilities of 1542770 B.C. Ltd. d/b/a Molecule.ai ("Molecule"), a Canadian artificial intelligence company specializing in molecular discovery and drug development technologies. Under the terms of the agreement, 1563868 B.C....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...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...Read more
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...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....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...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,...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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/...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...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:...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,...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...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,...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...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...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...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...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...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...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...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...Read more
| Company | Change | Last Trade |
|---|---|---|
| Regencell Bioscience | 3.59 27.59 | $16.60 |
| Harrow | 2.48 5.57 | $47.00 |
| PTC Therapeutics | 2.09 2.76 | $77.85 |
| Biogen | 1.23 0.68 | $181.98 |
| Bristol-Myers Squibb | 0.98 1.92 | $51.94 |
| Universe Pharmaceuticals | 0.59 16.71 | $4.12 |
| Teva Pharmaceutical | 0.58 2.08 | $28.41 |
| Indivior | 0.58 1.70 | $34.60 |
| Emergent BioSolutions | 0.45 3.88 | $12.05 |
| Novo Nordisk | 0.42 0.88 | $47.99 |
| Sonoma Pharmaceuticals | 0.41 12.97 | $3.57 |
| Kiniksa Pharmaceuticals | 0.40 0.99 | $40.99 |
| Supernus Pharmaceuticals | 0.34 0.76 | $45.10 |
| Bausch Health | 0.33 4.68 | $7.38 |
| BiomX | 0.25 5.54 | $4.76 |
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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