SOUL trial shows Rybelsus significantly lowers major cardiovascular events and CKD risk. Novo Nordisk's breakthrough.
Conexxence and Bomyntra denosumab biosimilars approved by FDA. Fresenius Kabi expands treatment options.
Qfitlia (fitusiran) approved for routine prophylaxis in hemophilia A and B patients. Sanofi's new treatment.
FDA issues complete response letter for Cardamyst nasal spray for PSVT conversion. Milestone Pharma's update.
FDA approves supplemental BLA for Tesamorelin (Egrifta WR) to reduce abdominal fat in HIV patients. Theratechnologies.
Pluvicto (lutetium Lu-177) approved for PSMA-positive metastatic prostate cancer. Novartis delays chemotherapy.
Merck KGaA collaborates with Zebra Technologies to enhance healthcare solutions.
Equillium announces topline data from Phase III Equator study on itolizumab for acute graft-versus-host disease.
Volt PFA System receives CE Mark approval in Europe for treating atrial fibrillation.
FDA approves Vykat XR for treating hyperphagia in Prader-Willi syndrome patients.
NICE UK endorses Blincyto with chemotherapy for treating acute lymphoblastic leukemia in adults.
NICE UK supports Breyanzi for treating relapsed/refractory large B-cell lymphoma post-chemoimmunotherapy.
EMA accepts GSK's application to expand Nucala's use for treating COPD.
NICE UK endorses Fintepla for treating seizures in Lennox-Gastaut syndrome for patients aged 2+.
Phase III results and real-world research highlight positive outcomes for nipocalimab in treating generalized myasthenia gravis.
European Commission approves Capvaxive, a 21-valent conjugate vaccine, for preventing invasive pneumococcal disease and pneumonia in adults.
FDA approves Blujepa (gepotidacin) for treating uncomplicated urinary tract infections in females and pediatric patients 12+
Merck enters exclusive license agreement for HRS-5346, an investigational oral lipoprotein(a) inhibitor for cardiovascular disease.
Phase II trial of WVE-N531 shows positive results in boys with Duchenne muscular dystrophy amenable to exon 53 skipping.
FDA approves Cabometyx for patients 12+ with previously treated unresectable locally advanced or metastatic pancreatic neuroendocrine tumors.
Tolebrutinib regulatory submission accepted for priority review by FDA for multiple sclerosis patients.
New study results reinforce Tagrisso as the backbone therapy for EGFR-mutated lung cancer across stages.
CLEAR study shows better early patient satisfaction and sexual function with UroLift vs. Rezūm for BPH.
Novo Nordisk enters license agreement with United Bio Technology for UBT-251 to treat obesity and type 2 diabetes.
Topline data indicate Refocus-ALZ did not meet primary, secondary, or exploratory biomarker endpoints.
Eli Lilly to acquire Aurka Pharma and AK-01, an Aurora kinase A inhibitor in early trials for solid tumors.
NMPA China approves Sycume (Teprotumumab-N01) for treating thyroid eye disease (TED).
FDA approves Keytruda, Herceptin, and chemotherapy for HER2-positive gastric cancer expressing PD-L1.
Cretostimogene Grenadenorepvec data shows best-in-class response durability for high-risk bladder cancer.
FDA declines camrelizumab combination
NMPA China approves Penpulimab (AK105) with chemotherapy for nasopharyngeal carcinoma treatment.
FDA grants exemption for coronary intravascular lithotripsy system to treat severe calcification before stenting.
FDA approves TLX007-CDx kit for Gallium-68 PET scanning of PSMA-positive prostate cancer lesions.
Tremfya (guselkumab) approved by FDA, offering subcutaneous and intravenous options for Crohn's disease treatment.
Cytokinetics launches Earth HCM, a new tool to educate and support the hypertrophic cardiomyopathy community.
Eyenovia Inc. and Betaliq Inc. announce merger to form a new ophthalmic company.
Stryker acquires Inari Medical, enhancing solutions for venous thromboembolism and clot removal.
Parateck announces acquisition of Optinose, including its product Xhance (fluticasone propionate).
DA to decide on ProSense marketing for early-stage, low-risk breast cancer with endocrine therapy by Q1 2025.
Allurion Balloon combined with low-dose GLP-1 therapy shows promising initial results for muscle mass optimization.
Amvuttra (vutrisiran) receives FDA approval for treating ATTR amyloidosis with cardiomyopathy (ATTR-CM).
Phase III trial of Zaltenibart for paroxysmal nocturnal hemoglobinuria (PNH) is now enrolling participants.
Fabhalta receives FDA approval for C3 glomerulopathy, reducing proteinuria. First treatment for this condition.
Tonix Pharmaceuticals' TNX-801 vaccine shows potential to slow the global spread of Mpox.
New data reveals 48-week remission in tardive dyskinesia treatment with Ingrezza valbenazine capsules.
Alvotech acquires Xbrane Biopharma's research operations, including XB-003 referencing Cimzia.
FDA grants 510(k) clearance for Monogram MBOS TKA robotic system for orthopedic surgery.
New data on investigational therapy for TK2 deficiency presented at MDA 2025 conference.
Servier and Black Diamond Therapeutics announce global licensing agreement for BDTX-4933.
Phase III results for onasemnogene abeparvovec in SMA patients aged 2-18 years announced.
Topline results from Phase III study of batoclimab in myasthenia gravis and Phase IIb study in CIDP.
Datroway, the first TROP-2 therapy for HR-positive, HER2-negative breast cancer, launched in Japan.
TNF Pharma initiates Phase IIb trial to evaluate oral Isomyosamine for chronic inflammation and muscle loss.
Nipocalimab receives fast track designation for treating Sjogren's disease by Johnson & Johnson.
Actinium Pharma announces trials of Actimab-A with Keytruda or Opdivo for multiple solid tumors.
FDA accepts BLA submission for AVT-03, a proposed biosimilar of Prolia and Xgeva by Alvotech and Dr. Reddy's.
European Commission approves Rytelo for transfusion-dependent anemia in myelodysplastic syndromes.
AstraZeneca's EneboPTH meets primary endpoint of normalizing serum calcium in hypoparathyroidism patients in CALYPSO Phase III trial.
Incyte's Phase III STOP-HS trial shows positive topline results for povorcitinib in moderate-to-severe hidradenitis suppurativa.
OPKO Health and Entera Bio collaborate to advance oral dual-agonist GLP-1/glucagon peptide for obesity treatment.
Neurocrine Biosciences' Kinect-HD data shows significant reduction in chorea with Ingrezza (valbenazine) for Huntington's disease.
Actinium Pharma's Actimab-A trial results for R/R acute myeloid leukemia published in Leukemia journal.
AstraZeneca's Imfinzi (durvalumab) approved by EU as the first immunotherapy for limited-stage small cell lung cancer.
Bayer's Finerenone receives FDA priority review for new indication in heart failure patients with LVEF of 40%.
AbbVie's Elahere (mirvetuximab soravtansine) demonstrates consistent survival benefit in long-term analysis for ovarian cancer.
Alarity Therapeutics presents new Phase II trial data on Stenoparib monotherapy in advanced ovarian cancer patients.
Genmab's RAINFOL-01 study shows 55.6% ORR in heavily pre-treated ovarian cancer patients with rinatabart sesutecan.
AstraZeneca announces acquisition of Esobiotec to advance its cell therapy ambitions and enhance treatment options.
ORCA Bio's ORCA-T shows positive results in Phase III PRECISION-T study for AML, ALL, high-risk MDS, and MPAL patients.
Phase III trials show once-daily oral two-drug regimen of doravirine/islatravir maintains HIV-1 viral suppression.
New study data shows zero HIV cases with Apretude (cabotegravir), the only long-acting injectable for PrEP.
EMBRACE Phase IIb study shows N6LS every four months keeps viral levels suppressed in stable HIV patients.
Positive results from REDEFINE-2 Phase III trial of once-weekly Cagrisema (cagrilintide + semaglutide)
FDA approves expanded label for Iluvien (fluocinolone acetonide) for chronic non-infectious uveitis treatment.
European Commission approves Breyanzi (liso-cel) for treating adult patients with RR follicular lymphoma.
European Commission approves Rxulti (brexpiprazole) for treating schizophrenia in adolescents aged 13+.
Complete response letter for SI-6603 (condoliase), a treatment reducing leg pain from lumbar disc herniation.
Eton Pharmaceuticals announces positive pivotal clinical study results for product candidate ET-600.
Mallinckrodt and Endo announce merger to form a single company, enhancing pharmaceutical capabilities.
Uplizna (inebilizumab) shows significant improvement in generalized myasthenia gravis symptoms over 52 weeks.
Roche licenses Petrelintide from Zealand Pharma to treat obesity, both as monotherapy and in combination with CT-388.
NICE ends appraisal for Tecentriq in untreated advanced NSCLC when platinum chemotherapy is unsuitable.
NICE issues negative appraisal for Vyloy in untreated Claudin 18.2-positive, HER2-negative advanced gastric cancer.
NICE approves Acarizax for moderate to severe house dust mite allergic rhinitis.
TNX-1500 demonstrates potential in preventing organ transplant rejections and treating autoimmune diseases.
European Commission approves Wainzua for hereditary transthyretin-mediated amyloidosis with polyneuropathy.
FDA grants 510(k) clearance for Monarch Quest, enhancing robotic-assisted bronchoscopy.
Ionis and Ono Pharma enter agreement for global rights to Sapablursen, targeting polycythemia vera.
Bristol Myers Squibb acquires 2seventy bio, including Abecma, a treatment for multiple myeloma.
Phase III study shows Felzartamab's effectiveness in treating late antibody-mediated rejection in kidney transplant patients.
FDA approves Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, for bone-related conditions.
Icotrokinra meets primary endpoint in ulcerative colitis study, potentially transforming treatment for patients.
Tonix Pharmaceuticals receives grant for developing TNX-801, a single-dose mpox and smallpox vaccine.
Johnson & Johnson's Icotrokinra results indicate potential new standard for plaque psoriasis treatment.
Sanofi and Regeneron present positive pivotal data for Dupixent in bullous pemphigoid at AAD.
Amgen and Kyowa Kirin reveal top-line results from Rocatinlimab Phase III study in atopic dermatitis.
Two-year SMART trial data confirms Evolut TAVR's superior valve performance over Sapien in small annulus patients, highlighting reduced bioprosthetic valve dysfunction and improved outcomes.
Phase III BRAVE-AA-PEDS study reveals Olumiant's efficacy in achieving significant hair regrowth for adolescents with severe alopecia areata, offering new hope for treatment.
Alyftrek, a next-in-class CFTR modulator by Vertex, gains UK MHRA approval for treating cystic fibrosis in patients aged 6 and older with specific genetic mutations.
Phase III POETYK PsA-2 trial data shows Sotyktu (deucravacitinib) significantly improves outcomes in adults with psoriatic arthritis, demonstrating superiority over placebo.
Three-year data shows Ebglyss (lebrikizumab-lbkz) delivers complete skin clearance in 50% of patients with moderate-to-severe atopic dermatitis, offering sustained relief.
Two-year AAD 2025 data highlights Bimzelx's potential to eliminate draining tunnels and reduce disease burden in moderate-to-severe hidradenitis suppurativa.
The European Commission has approved Opdivo (nivolumab) and Yervoy (ipilimumab) for first-line treatment of unresectable or advanced hepatocellular carcinoma, offering new hope for patients.
Five-year data from AAD 2025 highlights Bimzelx's sustained skin clearance and long-term efficacy in treating moderate-to-severe plaque psoriasis.
Bavarian Nordic's chikungunya vaccine application accepted by UK MHRA, potentially expanding protection to individuals aged 12 and older. Approval expected in 2025.
The MATTERHORN trial reveals that perioperative treatment with Imfinzi (durvalumab) and FLOT chemotherapy significantly enhances event-free survival in early-stage gastric and gastroesophageal cancers.
Results from a Phase 1 trial of Rhenium-186RNL for recurrent glioma, published in Nature Communications, highlight its potential to improve survival and progression-free outcomes for patients.
FDA approves Omlyclo (omalizumab-igec) as the first Xolair (omalizumab) biosimilar in the US, with interchangeability status, offering expanded treatment options for allergic and inflammatory conditions.
scPharmaceuticals Inc. announces FDA approval of sNDA for Furoscix, expanding its use to treat edema in chronic kidney disease (CKD) patients, offering new solutions for fluid overload management.
Jazz Pharmaceuticals to acquire Chimerix, including Dordaviprone for H3 K27M mutant glioma treatment.
FDA approves Revakinagene Taroretcel (LWY-ENCELTO) for treating macular telangiectasia type 2 (MacTel)
irst-generation oral pill norovirus vaccine shows promising results in elderly adults aged 55-80.
FDA accepts BLA for Deramiocel to treat Duchenne muscular dystrophy cardiomyopathy.
FDA approves Neffy epinephrine nasal spray for emergency allergic reactions and anaphylaxis.
FDA accepts sBLA for Gazyva (obinutuzumab) to treat lupus nephritis.
FDA reviews Depemokimab for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps.
Depemokimab delivers significant improvements for chronic rhinosinusitis with nasal polyps.
Forward intravascular lithotripsy platform launched in U.S. for calcified lesions.
Phase 3 trials show durable pain relief
NICE UK approves Casgevy for severe sickle cell disease in patients 12+
Preschool-aged child treated with arpraziquantel for schistosomiasis.
Enhertu improves overall survival in HER2-positive metastatic gastric cancer patients.
FDA approves TNKase (tenecteplase) for acute ischemic stroke in adults.
IBSRELA (tenapanor) approved to control serum phosphorus in dialysis patients with CKD
Boston Scientific to acquire Sonivie Ltd. and its TIVUS intravascular ultrasound system.
Phase III VERIFY study shows positive results for rusfertide in treating polycythemia vera by Protagonist and Takeda.
AbbVie to acquire rights to GUB-014295, a potential best-in-class long-acting amylin analog for obesity.
Eton Pharmaceuticals announces the commercial launch of Galzin (zinc acetate) capsules.
Eisai receives regulatory review outcome for lecanemab as a treatment for early Alzheimer's in Australia.
KalVista Pharma presents novel data on long-term prophylaxis and sebetralstat for hereditary angioedema.
Phase III study shows Xolair may be more effective with fewer side effects for food allergies by Roche.
FDA approves Odactra tablet for young children with house dust mite allergy by ALK.
Promising results from Phase II barzolvolimab studies in chronic urticaria patients by Celldex.
Kizfizo oral suspension not approved for relapsed or refractory high-risk neuroblastoma. Orphelia Pharma.
Tremfya approved for adults with moderate to severe ulcerative colitis after inadequate response. Johnson & Johnson.
CHMP gives positive opinion for Vyjuvek (beremagene geperpavec) to treat wounds in dystrophic epidermolysis bullosa patients.
CHMP gives positive opinion for Ixchiq, a single-dose vaccine by Valneva, for preventing chikungunya virus disease.
CHMP gives positive opinion for Fabhalta (iptacopan) by Novartis, for treating adults with C3 glomerulopathy (C3G).
CHMP gives positive opinion for Imfinzi (durvalumab) with chemotherapy as adjuvant treatment for resectable NSCLC.
CHMP gives positive opinion for Calquence (acalabrutinib) by AstraZeneca, for treating mantle cell lymphoma (MCL).
CHMP gives positive opinion for Lynozyfic (linvoseltamab) by Regeneron Pharma, for treating relapsed/refractory multiple myeloma.
Deqsiga receives CHMP positive opinion for treating primary and secondary immunodeficiencies.
Novartis completes acquisition of Anthos Therapeutics, expanding its cardiovascular treatment portfolio.
Jaypirca (pirtobrutinib) recommended by CHMP for EU approval in relapsed/refractory CLL treatment.
Phase III trial shows Jaypirca reduces disease progression or death risk by 46% in CLL patients.
Enhertu (trastuzumab deruxtecan) recommended by CHMP for HER2-low/ultralow metastatic breast cancer.
Moderna receives UK authorization for its RSV vaccine from the Medicines and Healthcare products Regulatory Agency.
CHMP reaffirms positive opinion for Lecanemab in early Alzheimer's disease treatment by Eisai and Biogen.
FDA approves Leqembi (lecanemab) for monthly maintenance dosing in early Alzheimer's disease treatment.
CHMP recommends EU approval of Columvi combination for relapsed/refractory diffuse large B-cell lymphoma.
BlueRock Therapeutics receives FDA Fast Track designation for OPCT-001 in primary photoreceptor diseases.
Serena-6 trial shows Camizestrant significantly improves progression-free survival in advanced HR+ breast cancer.
CHMP issues positive opinion for Rinvoq (upadacitinib) in treating adults with giant cell arteritis.
