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 lesions of rosacea in adults SCOTTSDALE,... 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 drug-delivery platform. The assessment... 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 after adjuvant endocrine therapy... 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® (tucatinib) as part of an investigational... 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, and Blink Rx LLC (“BlinkRx”),... 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 sepiapterin-responsive PKU.
"We're pleased 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 treatment suitable for most solid... 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 vials. This medicine is... 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 facility in Huntsville, Alabama. This... 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 differentiated LAI franchise... 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 investigational Phase 3 MajesTEC-3 study... 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 program INDIANAPOLIS, Dec. 9, 2025... 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, manufacturing and commercialization... 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 outcomes for more people with lymphoma... 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 first-in-class BCL6 ligand-directed degrader... 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 Prize-winning chemist whose work has fundamentally... 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 alternatives, like Caldolor, play a critical... 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, Israel, Dec. 08, 2025 (GLOBE NEWSWIRE)... 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 approved by Health Canada for adults... 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 $40 Million-$44 Million
Kamada... 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 included in the... 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 the treatment-naïve subgroup, which... 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 LBCL), even among those ineligible... 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 in improving key bleeding outcomes... 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 Support Planned 2026 Launch in the... 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 for its two investigational bicistronic... 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 CARTITUDE-4 study supporting durable tr... 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 Initially Randomized to Rusfertide,... 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 definitive agreements, Biocon will... 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 new data from the investigational... 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 demonstrated effectiveness in alleviating... 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 NEWSWIRE) -- Amneal Pharmaceuticals,... 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 granted approval of Breyanzi® (... 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 biopharmaceutical company specializing... 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, both in Rome, Italy.
18th International... 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 hematopoietic stem cell transplant-associated... 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 platform with the launch of its... 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 clinical study of a kidney disease... 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 research cooperation with Evotec,... 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, Mass., Dec. 3, 2025 /PRNewswire/ -- Eisai... 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, Dec. 3, 2025 /PRNewswire/ -- Eli... 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 designation was supported by promising... 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 study data, the company identified... 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 submissions to health authorities worldwide... 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 cerebrospinal fluid (CSF) was... 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 baxdrostat has been accepted for Priority... 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 deliver controlled, site-specific... 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 annually1 WOBURN, Mass., Dec. 02,... 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 research across multiple blood cancers... 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 120 countries, and approved in... Read more
