SAN DIEGO, Dec. 22, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its Phase 3 KINECT®-DCP study evaluating the efficacy, safety, and tolerability of valbenazine in pediatric and adult participants who have dyskinetic cerebral palsy (DCP) did not meet primary or key secondary endpoints. The primary objective of the study was to assess improvement in chorea, a type of involuntary movement,...Read more
Weekly Oral Helicase-Primase Inhibitor Programs' Early Data Potentially Supportive of First New Treatment for Recurrent Genital Herpes in 25 Years FOSTER CITY, Calif. & SOUTH SAN FRANCISCO, Calif. / Dec 22, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Assembly Biosciences, Inc. (Nasdaq: ASMB), today announced Gilead has exercised its combined option to exclusively license Assembly Bio’s herpes simplex virus...Read more
Tenth Breakthrough Therapy Designation for AstraZeneca and Daiichi Sankyo’s ENHERTU with the latest based on DESTINY-Breast05 Phase III trial results WILMINGTON, Del. / Dec 22, 2025 / Business Wire / AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the US for adult patients with HER2-positive early breast cancer with residual invasive disease in the...Read more
TOKYO / Dec 22, 2025 / Business Wire / Incyte Biosciences Japan G.K. today announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL). “Today's approval of Minjuvi in combination with rituximab and lenalidomide marks a significant milestone as the first dual-targeted CD19...Read more
TOKYO / Dec 22, 2025 / Business Wire / Incyte Biosciences Japan G.K. today announced the Japan Ministry of Health, Labour and Welfare (MHLW) approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). "Today's approval marks a significant milestone for patients with advanced anal cancer in Japan –...Read more
Lunsumio VELO reduces administration time from 2-4 hours to approximately one minute – Availability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences – Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse – SOUTH SAN FRANCISCO, Calif. / Dec 22, 2025 / Business Wire /...Read more
BioMarin to Gain Galafold® (migalastat) for Fabry Disease and Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) for Pompe Disease, Adding Two Marketed, High-Growth Products with $599 Million in Revenue Over Past Four Quarters Provides Opportunity to Expand Access to Galafold and Pombiliti + Opfolda to Patients in New Markets Across BioMarin's Global Footprint; Pending U.S. Galafold Patent Litigation Resolved Will...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
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
BioNTech has completed its exchange offer to acquire CureVac Acquisition complements BioNTech’s capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing In total, approximately 86.75% of CureVac shares were tendered; BioNTech expects to complete the compulsory acquisition of the remaining CureVac shares in January 2026 as part of the previously announced post-offer reorganization CureVac...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
Up to $54.3 million CEPI investment aims to help advance Moderna's H5 pandemic influenza vaccine candidate to licensure Partnership strengthens global preparedness against a significant pandemic threat If licensed and in the event of an influenza pandemic, Moderna will allocate 20% of its H5 pandemic vaccine manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing OSLO, NORWAY and...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
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
Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab is the first CD19- and CD20-dual-targeted immunotherapy combination regimen approved for eligible patients in Europe with relapsed or refractory FL Patients with relapsed or refractory FL achieved significantly improved progression-free survival with Minjuvi in combination with rituximab and lenalidomide in the Phase 3 inMIND registration trial In Western...Read more
New platform is expected to substantially increase manufacturing capacity and lower production costs, enabling investment in expanding pipeline FDA has accepted Alnylam’s enzymatic ligation manufacturing platform into its Emerging Technology Program, fast-tracking global regulatory engagement CAMBRIDGE, Mass. / Dec 17, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today...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
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
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
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
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
NEW YORK, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it has acquired a pre-existing royalty interest in Nuvalent’s neladalkib and zidesamtinib from an undisclosed third party for up to $315 million. Neladalkib and zidesamtinib are next-generation tyrosine kinase inhibitors (TKIs). Neladalkib is in development for patients with ALK mutation-positive non-small cell lung cancer (NSCLC) and...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
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
mNEXSPIKE is Moderna's third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and mRESVIA (Respiratory Syncytial Virus Vaccine) mNEXSPIKE will be available in the European Union, subject to authorization by the European Commission CAMBRIDGE, MA / ACCESS Newswire / December 15, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal...Read more
15 December, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Phase 3 UplighTED studies evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate to severe thyroid eye disease (TED) will be discontinued. The...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
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
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
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
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
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
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
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
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
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
Global interim Phase 2 data in locally advanced/metastatic triple-negative breast cancer (”TNBC”) show encouraging antitumor activity for investigational therapy pumitamig (BNT327/BMS986545) plus chemotherapy in first- and second-line patients Pumitamig plus chemotherapy achieved confirmed objective response rate (cORR) of 61.5%, unconfirmed ORR (uORR) of 71.8% and disease control rate (DCR) of 92.3% irrespective of PD-L1 expression...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
Two-year epcoritamab monotherapy data demonstrate high complete response and encouraging survival rates in patients with Richter transformation (RT), highlighting its potential as a treatment option for those unsuitable for chemotherapy Additional early data show promising efficacy of epcoritamab combination regimens in patients with RT Results underscore the potential of epcoritamab as a versatile therapy for a broad range of B-cell...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
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
All three dose groups (50 mg, 100 mg and 200 mg) showed impressive monotherapy efficacy, with VGPR+ (very good partial response or better) of ≥70% despite limited follow-up; evidence shows that these responses are expected to deepen over time Across all dose groups, 95% (19 of 20 patients) of all evaluable VGPR+ patients achieved minimal residual disease negative status Data featured in an ASH oral presentation; LINKER-MM4 is the...Read more
The Company plans to initiate a Phase 3 program evaluating INCA033989 in essential thrombocythemia (ET) patients with all types of CALR mutations in mid-2026, following alignment with regulators Updated safety and efficacy data for INCA033989 in ET, and new data in myelofibrosis (MF), will be presented at the upcoming 2025 ASH Annual Meeting WILMINGTON, Del. / Dec 07, 2025 / Business Wire / Incyte (Nasdaq:INCY) today announced that...Read more
Trial demonstrated treatment with fixed duration EPKINLY plus rituximab and lenalidomide (EPKINLY+ R2) resulted in statistically significant and clinically meaningful reduction in the risk of disease progression or death and overall response compared to R2 alone EPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific-based therapy for follicular lymphoma in the second-line...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
Selective Treg modulator gotistobart (BNT316/ONC-392) showed a reduction in the risk of death by more than half compared to standard of care chemotherapy and a manageable safety profile in the first of two stages of the global Phase 3 trial PRESERVE-003 in patients with squamous non-small cell lung cancer (“sqNSCLC”) who have progressed on prior immunotherapy plus chemotherapy Median OS with gotistobart has not been reached at almost...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
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
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
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
NEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Denali Therapeutics, Inc. (Nasdaq: DNLI) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali’s lead investigational TransportVehicleTM-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or...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
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
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
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
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
TSRA-196 is a potential one-time treatment to precisely correct the genetic mutation underlying AATD, with Investigational New Drug filing expected by the end of the year Tessera to receive $150 million, inclusive of a cash upfront and equity investment from Regeneron; companies to share worldwide development costs and future profits 50:50 Collaboration combines Regeneron’s long-standing expertise in genetics, genetic medicines and...Read more
WILMINGTON, Del. / Dec 01, 2025 / Business Wire / Incyte (Nasdaq:INCY) announces the appointment of Richard Hoffman as Executive Vice President and General Counsel effective today, December 1, 2025. In his new role, Mr. Hoffman will serve as a key member of the Executive Leadership Team and be responsible for the Company’s legal and compliance teams. “Richard joins us with a distinguished background, including many years of experience as a...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
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
Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo In the EU, there are approximately 270,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite standard-of-care antihistamine treatment Dupixent, which inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation, is now approved for patients across seven...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
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
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
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
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
Published, peer-reviewed narrative review in CNS Spectrums compiles pharmacologic, pharmacokinetic and clinical data of VMAT2 inhibitors to highlight important differences between treatments Review presents distinctive profile of INGREZZA, including selective VMAT2 targeting, simplified dosing without required titration and robust clinical data across diverse patient populations and concludes that VMAT2 inhibitors are not clinically...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
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
Non-dilutive financing from premier lender bolsters strong balance sheet and provides increased flexibility Company reiterates 2025 financial guidance provided on 3Q25 earnings call and targets cash breakeven by 2028 CAMBRIDGE, MA / ACCESS Newswire / November 20, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced it has closed a five-year term loan facility for up to $1.5 billion of capital from Ares Management Credit Funds (Ares),...Read more
First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period Monthly dosing option in all approved indications provides greater dosing flexibility for more personalized patient care TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA...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
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
New capabilities strengthen U.S. production, completing Moderna's domestic end-to-end mRNA manufacturing network More than $140 million investment will create hundreds of highly skilled biomanufacturing jobs CAMBRIDGE, MA / ACCESS Newswire / November 19, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced the expansion of its U.S. manufacturing capabilities with the onshoring of Drug Product manufacturing to its existing Moderna...Read more
Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to significantly improve disease-free survival in CSCC in the adjuvant setting, reducing the risk of recurrence or death by 68% (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001) Libtayo is the current standard of care in advanced CSCC in Europe, and this approval has the potential to change the treatment...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
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
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is the first and only bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line setting In the Phase 3 EPCORE® FL-1 trial, fixed duration EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2, with approximately three out of four patients achieving a complete response This...Read more
| Company | Change | Last Trade |
|---|---|---|
| Alnylam Pharmaceuticals | 4.46 1.12 | $401.72 |
| argenx | 1.73 0.21 | $839.63 |
| Vertex Pharmaceuticals | 1.71 0.38 | $455.45 |
| Neurocrine Biosciences | 0.79 0.56 | $141.74 |
| BioMarin Pharmaceutical | 0.42 0.71 | $59.41 |
| Johnson & Johnson | 0.38 0.18 | $207.29 |
| Biogen | 0.34 0.19 | $176.74 |
| Insmed | 0.29 0.17 | $174.39 |
| Incyte | 0.28 0.28 | $99.19 |
| AbbVie | 0.12 0.05 | $229.86 |
| Regeneron Pharmaceuticals | 0.11 0.01 | $774.05 |
| Bayer | 0.05 0.46 | $10.86 |
| Amgen | 0.04 0.01 | $328.73 |
| Gilead Sciences | 0.04 0.03 | $123.22 |
| Viatris | 0.03 0.24 | $12.57 |
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
CLICK TO LEARN MORE
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
CLICK TO LEARN MORE
