Proposed transaction aims to deliver near-term value for ProPhase shareholders, long-term growth for ABL, and create a global, innovation-driven company. Company to hold a virtual conference call today at 10:00 a.m. ET UNIONDALE, NY, Dec. 19, 2025 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH) ("ProPhase") and Advanced Biological Laboratories S.A. ("ABL"), a European biotechnology and MedTech group, today announced that they...Read more
In ATTAIN-MAINTAIN, orforglipron achieved the primary and all key secondary endpoints for weight maintenance vs. placebo at 52 weeks following weight loss on Wegovy or Zepbound Participants who switched to orforglipron from Wegovy maintained all but 0.9 kg of their previously achieved weight loss on average Lilly has submitted orforglipron to the U.S. Food and Drug Administration for the treatment of obesity INDIANAPOLIS, Dec. 18,...Read more
TRUFILL n-BCA is now indicated for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and Chronic Subdural Hematoma (cSDH) as an adjunct to surgery. Approval builds on a trusted solution in neurovascular embolization for over 25 years. IRVINE, Calif., Dec. 18, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Today, Johnson & Johnson MedTech, a leader in neurovascular care,...Read more
FOSTER CITY, Calif. / Dec 18, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) announced today that Keeley Wettan will be appointed Executive Vice President, General Counsel, Legal & Compliance effective immediately. She will join the company’s senior leadership team and report to Chairman and Chief Executive Officer Daniel O’Day. Ms. Wettan has held increasingly senior legal leadership roles within Gilead during her 14-year...Read more
Pivotal Phase 3 studies of once-daily oral zasocitinib met all primary and ranked secondary endpoints in patients with moderate-to-severe plaque psoriasis More than half of study participants treated with zasocitinib achieved clear or almost clear skin (PASI 90), and on average about 30 percent achieved completely clear skin (PASI 100) by week 16 Zasocitinib was generally well-tolerated with a safety profile consistent with previous...Read more
Receives U.S. Food and Drug Administration (FDA) Approval for Generic Version of Sandostatin® LAR Depot (Octreotide Acetate for Injectable Suspension) U.S. FDA Accepts New Drug Application for Low Dose Estrogen Weekly Patch for Contraception U.S. FDA Clears Investigational New Drug Application for MR-146 in Neurotrophic Keratopathy Japan Pharmaceuticals and Medical Devices Agency Accepts Japanese New Drug Application Filing for...Read more
Conditional Approval Marks Elanco's Third New World Screwworm Treatment Option for Companion Animals, Providing Multiple Treatment Solutions Prior to Fly Being Detected in the U.S. FDA's Conditional Approval of Credelio Quattro-CA1 (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is the first for companion animals against New World screwworm Action follows previous Emergency Use Authorizations granted by the...Read more
WARREN, N.J., Dec. 18, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that CEO Matthew B. Klein, M.D., will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 12, 2026, at 9 a.m. PST/12 p.m. EST. The presentation will be webcast live on the Events and Presentations page of the Investors section of the PTC Therapeutics website at...Read more
Data expected in Q2 2026 DUBLIN, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH). REVITALYZ is a double-blind,...Read more
Jack Bendheim to Assume the Role of Executive Chairman; Daniel Bendheim Named Chief Executive Officer and President TEANECK, N.J. / Dec 18, 2025 / Business Wire / Phibro Animal Health Corporation (Nasdaq: PAHC) (the “Company” or “Phibro”) today announced a leadership transition that will support the Company’s continued growth and long-term strategic direction. At the end of this fiscal year, effective July 1, 2026, Jack Bendheim,...Read more
MONTREAL, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved WYNZORA®, a white uniform cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12-17 years for up to 8...Read more
RYBREVANT FASPRO™, the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, reduces administration time from hours to minutes and significantly reduces administration-related reactions1-5 Approval builds on previously reported Phase 3 MARIPOSA data showing unmatched overall survival benefit of this chemotherapy-free regimen, projected to exceed four years6 HORSHAM, Pa., Dec. 17, 2025 /PRNewswire/ -- Johnson...Read more
First and only immunotherapy plus ADC regimen, used perioperatively, to extend survival for cisplatin-eligible patients with MIBC RAHWAY, N.J. / Dec 17, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based...Read more
PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients with muscle-invasive bladder cancer Positive EV-304 data, combined with the recent unprecedented results from the EV-303 trial, highlight the potential of this combination to become a new platinum-free standard of care in an earlier stage of...Read more
PITTSBURGH, Dec. 17, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the Company will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, Jan. 13, 2026. The Company's presentation and fireside chat will begin at 9 a.m. PT / 12 p.m. ET. A live webcast of the event can be found at investor.viatris.com. An archived version of the...Read more
Both monthly maintenance doses (100 mg and 300 mg) improved opioid abstinence and were well-tolerated with no new safety signals identified. Post-hoc analyses indicated the 300-mg monthly maintenance dose performed significantly better than the 100-mg monthly dose in participants reporting high-frequency fentanyl use. RICHMOND, Va., Dec. 17, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) today announced...Read more
Agreement Calls for Development Services and Tech Transfer in Preparation for Commercial Manufacturing of Injectable Pharmaceutical Product Partner’s Program Size Positions it to Become a Top Five Commercial Customer for Lifecore CHASKA, Minn., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced that...Read more
Following positive efficacy and safety results from Phase 2b QUALITY study, company received FDA regulatory clarity for enobosarm in combination with GLP-1 RA Incremental weight loss is an acceptable approvable primary endpoint with key secondary endpoints on physical function and body composition improvements Company plans to initiate Phase 2 PLATEAU clinical study in calendar Q1 2026 Post fiscal year end, company...Read more
The new cobas® 6800/8800 Systems version 2.0 and software version 2.0.1 enhances throughput, run flexibility, enables sample prioritization and is available as an upgrade to existing systems. Laboratories can now perform a greater variety of tests per run, simplifying laboratory logistics and helping to optimize the use of resources. The update addresses critical industry challenges, such as staffing shortages, rising costs and menu...Read more
Continued Investment in Pipeline and Acquired Assets in 2026 to Fuel Long-Term Growth Reaffirms Full-Year 2025 Adjusted(1) Diluted EPS Guidance(2) and Revises Full-Year 2025 Revenue Guidance(2) to Approximately $62.0 Billion Full-Year 2026 Revenue Guidance(2) Range of $59.5 to $62.5 Billion Full-Year 2026 Adjusted(1) Diluted EPS Guidance(2) Range of $2.80 to $3.00 NEW YORK / Dec 16, 2025 / Business Wire / Pfizer Inc. (NYSE:PFE)...Read more
Exdensur is the first and only ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype Approval based on SWIFT trials showing significantly lower rate of annualized asthma exacerbations in patients receiving depemokimab versus placebo SWIFT data included reduction in exacerbations requiring hospitalization and/or emergency department visits with depemokimab An...Read more
TORONTO, Dec. 16, 2025 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that FRUZAQLATM (fruquintinib capsules) will now be reimbursed by BC Cancer as a treatment option for adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates, for available standard therapies.[1] This treatment is available to patients under certain criteria. "Colorectal cancer...Read more
First-in-human trial of candidate from the next-generation ATTC platform Simultaneous China and global clinical development strategy to expedite development process HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the initiation of its global Phase I clinical development program for HMPL-A251, a first-in-class...Read more
Based on DESTINY-Breast09 Phase III trial results that showed AstraZeneca and Daiichi Sankyo’s ENHERTU in combination with pertuzumab reduced the risk of disease progression or death by 44% vs. THP with a median progression-free survival of more than three years WILMINGTON, Del. / Dec 15, 2025 / Business Wire / AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been approved...Read more
Investigational Treatment Regimen Could Expand Options for Virologically Suppressed Adults Positive Phase 3 Results from Both ARTISTRY-2 and ARTISTRY-1 Trials will Form the Basis of Regulatory Submissions FOSTER CITY, Calif. / Dec 15, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ARTISTRY-2 trial. The double-blind trial evaluated the treatment...Read more
RANCHO CUCAMONGA, CA / ACCESS Newswire / December 15, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen. The FDA determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's...Read more
Clinical Development Program Appropriate for Rolling BLA Submission Expected by the End of 2025 CANTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the successful completion of a...Read more
As monotherapy, imlunestrant demonstrated an 11.4-month numeric improvement in median OS versus endocrine therapy in patients with ESR1-mutated disease In all patients, the imlunestrant plus abemaciclib combination achieved a median PFS of 10.9 months, demonstrated a favorable OS trend, and extended time to chemotherapy by more than a year These data were published simultaneously in Annals of Oncology and will be presented today at...Read more
Expanded indication for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone marks the first FDA-approved precision medicine combination treatment for patients with BRCA2-mutated mCSPC HORSHAM, Pa., Dec. 12, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for AKEEGA® (niraparib and...Read more
RAHWAY, N.J. / Dec 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of an expanded indication for WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional...Read more
GAITHERSBURG, Md., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for its Winnipeg, Canada facility to be added as the drug product manufacturing and testing site for raxibacumab, a monoclonal antibody for the treatment and prophylaxis of inhalational anthrax. “We are pleased with the...Read more
In TRIUMPH-4, participants with obesity and knee osteoarthritis taking retatrutide 12 mg lost an average of 28.7% of their body weight at 68 weeks Retatrutide reduced WOMAC pain scores by up to an average of 4.5 points (75.8%) and significantly improved measures of physical function, with more than 1 out of 8 retatrutide-treated patients completely free from knee pain at the end of the trial Seven additional Phase 3...Read more
UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing* First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and anti-MuSK Ab+ gMG THOUSAND OAKS, Calif., Dec. 11, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are...Read more
The U.S. FDA assigned a target action date of April 8, 2026 PRINCETON, N.J. / Dec 11, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and...Read more
Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third experience recurrence on or...Read more
TUKYSA, trastuzumab, and pertuzumab reduced the risk of disease progression or death by 36% compared to trastuzumab and pertuzumab alone in Phase 3 HER2CLIMB-05 study The combination demonstrated a manageable safety profile as a first-line maintenance therapy NEW YORK / Dec 10, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced detailed results from the Phase 3 HER2CLIMB-05 trial of the tyrosine kinase inhibitor TUKYSA®...Read more
Broad label includes all age groups and full range of PKU subtypes TORONTO, Dec. 10, 2025 /CNW/ - PTC Therapeutics Canada ULC announced that Health Canada has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month old and older with...Read more
MELBOURNE, Australia and PALO ALTO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces a strategic clinical collaboration with Varian, a Siemens Healthineers company and global leader in radiation oncology, to develop novel clinical applications that combine Telix’s theranostic products and external beam radiation therapy (EBRT). EBRT is a widely used and validated...Read more
Clinical trial achieved all three primary objectives with no significant safety issues being reported Results indicate that Emrosi can be safely used for up to 16 weeks with no detectable impact on skin, GI tract or vaginal microbiota FDA-approved Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) is available in the United States for the treatment of inflammatory...Read more
U.S. Losartan market totals $245M annually with 71M prescriptions COMMACK, NY, Dec. 10, 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, and distribution of novel specialty products that address unmet market needs,...Read more
R&D assessment shows the platform can incorporate different drug entities onto its sustained-release matrix, supporting long-term potential to reduce or eliminate reliance on medicated eye drops TEL AVIV, Israel, Dec. 10, 2025 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) today announced that its pharmaceutical division has completed an R&D assessment of LayerBio’s proprietary drop-less, sustained-release ocular...Read more
The risk reduction observed in BRUIN CLL-313 is among the most compelling observed for a single agent BTK inhibitor in a front-line CLL study These data will be simultaneously published in the Journal of Clinical Oncology and highlighted in a late-breaking oral presentation at the 2025 American Society of Hematology Annual Meeting and Exposition, and were featured as part of the meeting's press...Read more
Huntsville site will focus on domestic production of small molecule synthetic and peptide medicines, including Lilly's oral GLP-1, orforglipron Company plans to create 3,450 manufacturing and construction jobs at Lilly's ninth U.S. manufacturing site announced since 2020 INDIANAPOLIS, Dec. 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced plans to invest more than $6 billion in a new manufacturing...Read more
TECVAYLI® and DARZALEX FASPRO® combination led to a statistically significant progression-free survival and overall survival advantage compared to standard treatment after three years of follow-up Combination regimen granted Breakthrough Therapy Designation by U.S. FDA ORLANDO, Fla., Dec. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma, today announced new data from the...Read more
Augments Pfizer’s efforts to advance investigational medicines for cardiometabolic diseases NEW YORK / Dec 09, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced it has entered into an exclusive global collaboration and license agreement with YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Limited (02196.HK and 600106.SH), a leading innovation-driven global healthcare company, for the development,...Read more
Olanzapine long-acting injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation, for a broad patient population1 Olanzapine LAI is designed to help support real-world adherence and improved stability, with the goal of addressing a critical treatment gap for people living with schizophrenia1 Teva is committed to advancing this innovative treatment option and further build on its...Read more
Expands Amneal’s injectables portfolio with an essential medicine used in hospitals for emergency and perioperative care BRIDGEWATER, N.J., Dec. 09, 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 epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose...Read more
INDIANAPOLIS, Dec. 8, 2025 /PRNewswire/ -- The board of directors of Eli Lilly and Company (NYSE: LLY) elected Carolyn R. Bertozzi, Ph.D., as a returning member, effective Dec. 8, 2025. She will serve on the board's Science and Technology and Ethics and Compliance committees. "On behalf of Lilly and the entire board, I would like to welcome Carolyn back to Lilly," said David A. Ricks, Lilly chair and CEO. "Carolyn is a Nobel...Read more
Lunsumio in combination with lenalidomide may offer an effective treatment in relapsed or refractory follicular lymphoma based on first data from single-arm cohort of Phase III CELESTIMO study Data from subcutaneous Lunsumio plus Polivy reinforce its outpatient, chemotherapy-free potential in people with R/R large B-cell lymphoma Results highlight the potential of innovative Lunsumio combination regimens to offer improved...Read more
KIRKLAND, QC, Dec. 8, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the province of Saskatchewan has added CAPVAXIVE®, a 21-valent pneumococcal conjugate vaccine, to its publicly funded adult immunization program. This addition supports increased access to pneumococcal immunization for eligible adults in accordance with the provincial eligibility criteria. CAPVAXIVE® is...Read more
PRINCETON, N.J. / Dec 08, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) reinforces its hematology leadership through new research across multiple therapies for patients with lymphoma at the 67th American Society of Hematology (ASH) Annual Meeting. Highlights include updates from the company’s targeted protein degradation pipeline, including data on first-in-class investigational lymphoma CELMoD™ agent golcadomide and...Read more
Based on the Results of a Planned Interim Futility Analysis the Inhaled AAT Trial is Unlikely to Demonstrate a Statistically Significant Benefit in its Primary Endpoint Kamada Continues to Supply GLASSIA®, its AAT-IV Treatment, Marketed Internationally Including in the U.S. and Canada Through a License Agreement with TAKEDA Kamada Reiterates its 2025 Full-Year Revenue Guidance of $178 Million-$182 Million and Adjusted EBITDA of...Read more
NASHVILLE, Tenn., Dec. 8, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), today announced an important update regarding its Caldolor® (ibuprofen) Injection. The product's permanent J-code, J1741, is now officially associated with a reimbursement price, providing healthcare providers with a CMS-covered, non-opioid option for managing pain and fever. As the nation continues to face an opioid crisis, non-opioid...Read more
Following internal analysis and Data Monitoring Committee (DMC) feedback, the Company has elected to discontinue the BX004 Cystic Fibrosis (CF) Phase 2b trial BiomX continues to see potential in BX011, its phage program for Staphylococcus aureus (S. aureus) infections associated with diabetic foot infections (DFI). The Company is also implementing cost cutting measures, while evaluating strategic alternatives NESS ZIONA,...Read more
In addition to meeting the primary endpoint of non-inferiority for overall response rate (ORR) in the BRUIN CLL-314 study, pirtobrutinib achieved a numerically higher ORR of 87.0% compared to 78.5% for ibrutinib in the intent-to-treat (ITT) population Progression-free survival data were immature but trended in favor of pirtobrutinib with a 43% reduction of the risk of disease progression or death in the ITT population, and...Read more
Benefits Seen Regardless of Eligibility for Previous Standard of Care of High-Dose Chemotherapy and Stem Cell Transplant for Second-Line Treatment SANTA MONICA, Calif. / Dec 07, 2025 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), presented a new analysis today demonstrating that second-line Yescarta® (axicabtagene ciloleucel) therapy offers consistent benefits in patients with relapsed/refractory large B-cell lymphoma (R/R...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 08, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that following the contract renewal with the China National Healthcare Security Administration (“NHSA”), the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 2026 will continue to include ELUNATE®, ORPATHYS® and SULANDA®. In addition, TAZVERIK® will be...Read more
Follow-up data from CARTITUDE-4 show at least 80 percent of as-treated standard-risk patients remained progression and treatment-free following a single infusion as early as second line Data suggest stronger immune fitness in earlier lines may be associated with longer progression free survival ORLANDO, Fla., Dec. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today updated results from the Phase 3...Read more
96% Overall Response Rate, 74% Stringent Complete Response/Complete Response, and 95% Minimal Residual Disease Negativity Observed at a Median 15.9-months of Follow-up, with Responses Continuing to Deepen Over Time Observed Safety Profile is Predictable and Manageable to Date; No Delayed Neurotoxicities or Immune Effector Cell-Associated Enterocolitis across Phase 1 and 2 (iMMagine-1) Studies Data from Investigational Agent Anito-cel...Read more
Initial Results from Kite-753, Optimized with Novel Manufacturing Process That Preserves T-Cell Fitness, Show High Complete Response Rate and Favorable Safety Trend Novel Construct for Two Investigational Therapies Could Enable Safer, More Effective and Accessible CAR Ts SANTA MONICA, Calif. / Dec 06, 2025 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), presented Phase 1 data today with encouraging efficacy and safety results...Read more
Findings from the Phase 3 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition and published in Blood NEW YORK / Dec 06, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. The results demonstrated the superiority of HYMPAVZI...Read more
52-Week Results from the Phase 3 VERIFY Study of Rusfertide Demonstrated Sustained Hematocrit Control and Response, Defined by Absence of Phlebotomy Eligibility, with No New Safety Signals These Data Build on Positive 32-Week Primary Analysis from VERIFY, Which Met its Primary Efficacy Endpoint and All Four Key Secondary Endpoints Patients Crossing Over from Placebo to Rusfertide at 32 Weeks Achieved a Similar Response Rate to Those...Read more
Viatris to Receive $400 Million in Cash and $415 Million in Equity Shares of Biocon Limited Transaction Accelerates the Expiration of Biosimilars Non-Compete Restrictions PITTSBURGH, Dec. 6, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) today announced that it has entered into definitive agreements with Biocon Limited ("Biocon") for the sale of Viatris' equity stake in Biocon Biologics Limited ("Biocon Biologics"). Under the...Read more
New data from Cohort 4 of the SunRISe-1 study show more than 95 percent of patients remained progression free at one year, with more than 92 percent not undergoing bladder removal Patients with this type of bladder cancer have limited choices beyond radical cystectomy, highlighting the need for newer therapies for bladder preservation RARITAN, N.J., Dec. 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today that...Read more
PARSIPPANY, N.J. / Dec 05, 2025 / Business Wire / Zoetis Inc. today announced that Health Canada has approved Portela™ (relfovetmab injection) for the alleviation of pain associated with osteoarthritis (OA) in cats. Designed to provide three months of OA pain relief with a single injection, Portela targets anti-nerve growth factor (NGF), which is a key mediator of OA pain and inflammation. In a nine-month field trial in Europe, Portela...Read more
Interim data show substantial improvements in “Good On” time compared to other oral CD/LD therapies CREXONT delivered substantial “Off” time reductions, improved motor symptom control and provided a longer duration of benefit with each dose Findings highlight CREXONT as a key therapy in a category with limited innovation ELEVATE-PD study is ongoing with longer-term data expected in 2026 BRIDGEWATER, N.J., Dec. 05, 2025 (GLOBE...Read more
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
In the MZL cohort of TRANSCEND FL, Breyanzi delivered deep and durable responses in 95.5% of patients while demonstrating a consistent safety profile Breyanzi is now the only CAR T cell therapy approved by the FDA for five cancer types, the most of any CD19-directed CAR T cell therapy PRINCETON, N.J. / Dec 04, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has...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
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
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
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
| Company | Change | Last Trade |
|---|---|---|
| Eli Lilly | 14.56 1.38 | $1,071.44 |
| Biogen | 4.89 2.88 | $174.80 |
| PTC Therapeutics | 3.98 5.34 | $78.57 |
| AbbVie | 3.90 1.75 | $226.72 |
| Amgen | 2.96 0.91 | $327.38 |
| Gilead Sciences | 2.82 2.32 | $124.29 |
| Supernus Pharmaceuticals | 2.20 4.46 | $51.48 |
| Harrow | 1.84 4.13 | $46.40 |
| Kiniksa Pharmaceuticals | 1.19 2.83 | $43.19 |
| Roche | 1.03 2.05 | $51.31 |
| Regencell Bioscience | 0.89 4.70 | $19.81 |
| Bristol-Myers Squibb | 0.86 1.61 | $54.19 |
| Novartis | 0.79 0.58 | $136.06 |
| AstraZeneca | 0.75 0.83 | $91.36 |
| Novo Nordisk | 0.48 1.01 | $48.09 |
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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