Pfizer withdraws Ngenla (somatrogon) application for marketing authorisation variation for growth hormone deficiency in adults.
ALK's Itulazax approved in EU for treating tree pollen allergy in young children and adolescents, enhancing allergy care.
Eton submits NDA for ET-600 (Desmopressin Oral Solution) to FDA, aiming to treat central diabetes insipidus in pediatric patients.
AstraZeneca discontinues Capitello-280 Phase III trial of Truqap (capivasertib) in metastatic castration-resistant prostate cancer.
Pacira's PCRX-201 shows sustained improvements in knee pain, stiffness, and function after single administration for osteoarthritis.
CHMP endorses Roche's Phesgo for at-home administration, offering a subcutaneous option for HER2-positive breast cancer treatment.
CHMP recommends Xofluza (Baloxavir Marboxil) for treating uncomplicated influenza in infants in the EU, Roche announces.
Regeneron's Lynozyfic (Linvoseltamab) approved in EU for treating relapsed/refractory multiple myeloma, enhancing patient care.
Abbott integrates Libre's data with Epic's EHR system, offering seamless glucose monitoring for healthcare professionals.
Sasanlimab combo boosts event-free survival in BCG-naive high-risk non-muscle invasive bladder cancer, says Pfizer.
FDA grants Breakthrough Device Designation for Roche's AI-driven companion diagnostic for non-small cell lung cancer, enhancing precision.
CHMP adopts positive opinion for marketing authorization change for Seqirus Aflunov, expanding use to children from 6 months.
Highlights from AUA meeting: Phase IIB SunRISe-1 study shows TAR-200's efficacy in BCG-unresponsive bladder cancer.
Merck KGaA to acquire SpringWorks Therapeutics, enhancing its biopharmaceutical capabilities.
Keytruda (pembrolizumab) sets new standard of care for resectable locally advanced HNSCC, says Merck Inc.
European Commission grants standard marketing authorization for Filspari to treat primary IgA nephropathy in adults.
Filspari receives standard marketing authorization for adults with primary IgA nephropathy, enhancing treatment options.
CHMP recommends marketing authorization change for Jivi (damoctocog alfa pegol) to enhance treatment for Hemophilia A.
CHMP gives positive opinion on marketing authorization variation for Calquence in combination with venetoclax for untreated CLL.
CHMP recommends Amvuttra (vutrisiran) for treating ATTR amyloidosis with cardiomyopathy, enhancing patient care.
CHMP recommends approval of Oczyesa (octreotide) for treating acromegaly in the EU, improving patient outcomes.
CHMP gives positive opinion for Vyvgart (efgartigimod alfa) subcutaneous injection to treat CIDP, improving patient care.
CHMP adopts positive opinion recommending a change to marketing authorization for Veklury (remdesivir) to treat COVID-19.
EMA recommends Cystadrops (mercaptamine) for infants with cystinosis, offering new treatment options and improving care.
CHMP adopts positive opinion recommending marketing authorization for Enwylma (denosumab biosimilar) to treat osteoporosis.
CHMP gives positive opinion for Ziihera (zanidatamab) to treat advanced HER2-positive biliary tract cancer, enhancing patient care.
CHMP gives positive opinion for Junod and Yaxwer (denosumab biosimilars) to treat bone disease and osteoporosis, enhancing care.
CHMP adopts positive opinion for granting marketing authorization for Zadenvi (denosumab biosimilar) to treat osteoporosis.
CHMP gives favorable opinions for Biocon Biologics' denosumab biosimilars in Europe, enhancing treatment options for patients.
CHMP adopts positive opinion recommending marketing authorization for Denbrayce (denosumab biosimilar) to treat osteoporosis.
CHMP adopts positive opinion recommending marketing authorization for Izamby (mabxience research) to treat osteoporosis.
EMA supports broad label for all ages and severities
CHMP recommends EU approval for Duvyzat (givinostat) to treat Duchenne muscular dystrophy, enhancing patient care.
CHMP gives positive opinion for Dazublys (trastuzumab biosimilar) to treat cancer, enhancing patient care and treatment options.
CHMP adopts positive opinion for Tepezza (teprotumumab) to treat moderate to severe thyroid eye disease in adults, enhancing care.
CHMP recommends Adcetris (brentuximab vedotin) with Brecadd chemotherapy to treat Hodgkin lymphoma stages IIB-IV, enhancing care.
CHMP gives positive opinion for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), a new CFTR modulator for treating cystic fibrosis.
CHMP endorses Attrogy for treating hereditary transthyretin-mediated amyloidosis in adults with stage 1 or 2 polyneuropathy
Johnson & Johnson's OmnyPulse Platform shows high acute effectiveness and promising safety for AFib in 3-month trial data.
Phase III BOND-003 study data shows durable efficacy of CG Oncology's Cretostimogene for high-risk NMIBC, promising bladder-sparing therapies.
Volt CE Mark Study data shows Abbott's Volt PFA System delivers long-term safety and efficacy for AFib patients, with significant QoL improvements.
Medtronic's Expand URO trial confirms Hugo RAS system meets primary safety and effectiveness endpoints for urologic procedures.
Medtronic's Affera PFA technologies show promising safety and efficacy for AFib patients, with durable arrhythmia control.
MHRA UK approves Acoramidis (Beyonttra) for treating cardiomyopathy caused by transthyretin amyloidosis, offering new hope.
Improved motor control, fewer side effects
FDA approves penpulimab-kcqx for first-line and monotherapy treatment of non-keratinizing nasopharyngeal carcinoma.
Biohaven withdraws Dazluma application for spinocerebellar ataxia from EMA due to concerns about effectiveness and classification.
FDA approves Medtronic's OmniaSecure lead, the smallest lumenless defibrillation lead, with promising clinical study results.
Boehringer Ingelheim and Tessellate Bio partner to develop first-in-class precision treatments for hard-to-treat cancers.
Boehringer Ingelheim and Cue Biopharma collaborate to advance innovative treatments for autoimmune diseases.
Astellas and JFCR collaborate to fast-track translational and clinical oncology research advancements.
Study confirms long-term efficacy and safety of Ingrezza (valbenazine) for older adults with tardive dyskinesia.
Phase IIb study highlights promising results for TAR-200 in high-risk non-muscle invasive bladder cancer.
The New England Journal of Medicine publishes Phase III trial results showing Xofluza (baloxavir marboxil) significantly reduces influenza virus transmission with a single oral dose.
Boston Scientific's ADVANTAGE AF trial demonstrates the Farapulse Pulsed Field Ablation System's safety and effectiveness in treating persistent atrial fibrillation.
AbbVie seeks FDA approval for TrenibotulinumtoxinE (Trenibote), a neurotoxin designed for rapid onset and shorter duration in treating moderate to severe glabellar lines.
NICE UK endorses Rubraca (rucaparib) for maintenance treatment of advanced ovarian, fallopian tube, and peritoneal cancer after response to first-line platinum-based chemotherapy.
Endo launches a spatial computing injection simulator, blending physical and digital tools to enhance urology specialists' skills in treating Peyronie's disease with Xiaflex.
Daiichi Sankyo submits a supplemental New Drug Application for Enhertu (trastuzumab deruxtecan) in Japan, targeting HER2-positive metastatic solid tumors with promising Phase II trial results.
NICE UK endorses Joenja (leniolisib) for treating activated phosphoinositide 3-kinase delta syndrome (APDS) in patients aged 12 and older, offering targeted therapy for this ultra-rare condition.
Neurelis secures FDA approval for Valtoco (diazepam nasal spray), offering a noninvasive treatment for seizure clusters in patients aged 2 and older.
NICE UK halts appraisal of Tevimbra (tislelizumab) for untreated advanced non-small cell lung cancer due to lack of evidence submission by BeiGene/BeOne Medicines.
NICE UK recommends Lagevrio (molnupiravir) for treating mild to moderate COVID-19 in adults at risk of severe disease, offering a new option when other treatments are unsuitable.
Medtronic submits FDA applications for interoperable insulin pump and SmartGuard algorithm, paving the way for enhanced diabetes management in partnership with Abbott CGM.
Discover Ipsen's late-breaking data on Elafibranor (Iqirvo) for Primary Sclerosing Cholangitis (PSC), highlighting its favorable safety profile and significant efficacy in Phase II trials.
Roche's chest pain triage algorithm, CE-marked for quicker, accurate Acute Coronary Syndrome detection.
MHRA approves Hympavzi for treating haemophilia A and B in adults and children, marking a significant advancement in care.
Ivonescimab + chemotherapy show strong Phase III results for first-line treatment of advanced squamous NSCLC.
FDA clears Phasix ST Umbilical Hernia Patch, marking its commercial launch for effective hernia treatment.
Novavax seeks FDA approval for its COVID-19 vaccine, marking a significant step in the fight against the pandemic.
NICE recommends Joenja for treating APDS, offering new hope for patients with this rare immune disorder.
Phase III ARISE trial shows promising results for Cobenfy as an adjunctive treatment in adults with schizophrenia.
Phase IIIb trial results show Adstiladrin's efficacy in BCG-unresponsive CIS ± high-grade Ta/T1 patients in Japan.
MHRA approves Blenrep combinations for treating relapsed/refractory multiple myeloma, offering new therapeutic options.
Diabetes Care publishes results from Corcept's Catalyst trial on difficult-to-control type 2 diabetes prevalence phase.
Regeneron and Bayer provide an update on Eylea HD aflibercept injection 8 mg supplemental biologics license application.
Trodelvy + Keytruda improves progression-free survival in untreated PD-L1+ metastatic triple-negative breast cancer.
Enhertu + Perjeta shows significant improvement in progression-free survival for HER2+ metastatic breast cancer.
FDA approves Simplera Sync sensor for Medtronic's MiniMed 780G insulin delivery system.
Dupixent approved in the US as the first new targeted therapy for chronic spontaneous urticaria in over a decade.
UK MHRA approves new combination therapy for relapsed/refractory multiple myeloma.
ohnson & Johnson's Apalutamide demonstrates consistent 24-month overall survival in prostate cancer patients.
Altor BioScience files sBLA for Nogapendekin Alfa to treat BCG-unresponsive nonmuscle invasive bladder cancer.
Eight-year data shows Resilia-treated aortic valves significantly improve long-term outcomes.
NICE recommends Jakafi for treating acute graft-versus-host disease in patients 12+.
BMS's Camzyos did not meet primary endpoints in treating non-obstructive hypertrophic cardiomyopathy.
Eli Lilly's oral GLP-1, Orforglipron, shows significant efficacy and safety in Phase III trial.
Pfizer's Penbraya approved by FDA for preventing five common meningococcal serogroups in adolescents.
ACIP votes to include adults 50-59 at risk in RSV vaccine Abrysvo recommendation.
BlueRock Therapeutics publishes 18-month data from Phase I trial for Parkinson's cell therapy.
GSK's Arexvy recommended for adults 50-59 at risk for severe RSV by US advisory committee.
Pfizer's MenABCWY pentavalent vaccine meets primary endpoints, set for BLA.
Pfizer's MenABCWY vaccine for meningococcal disease accepted for BLA by FDA.
GSK's 5-in-1 meningococcal vaccine Penmenvy receives positive recommendation from US advisory committee.
Isturisa approved for broader use in Cushing's syndrome treatment.
FDA grants RMAT designation to LYL-314 for treating large B-cell lymphoma.
Leqembi becomes first EU-approved drug to slow early Alzheimer's progression.
Valneva receives first marketing authorization for Ixchiq vaccine in chikungunya-endemic country.
FDA designates Yuflyma as interchangeable with Humira, says Celltrion Inc.
Sandoz files antitrust litigation against Amgen over etanercept biosimilar access.
Phase II study shows amlitelimab's efficacy in treating heterogeneous inflammatory asthma.
Preliminary results from SHIELD Utah study show promise for Novavax's COVID-19 vaccine.
AXS-05 demonstrates efficacy and safety in Alzheimer's agitation Phase III trial.
Camzyos did not meet primary endpoints in NHCM treatment, says BMS.
FDA mandates Phase III trial for apraglutide approval in short bowel syndrome patients.
Soligenix announces interim results from Hybryte study in early-stage cutaneous T-cell lymphoma.
Johnson & Johnson MedTech completes first gastric bypass surgery using Ottava robotic system.
Eisai provides update on European Commission's regulatory review of Lecanemab for early Alzheimer's.
Bayer's Vitrakvi receives FDA approval for treating NTRK gene fusion-positive solid tumors.
Roche's Columvi approved by European Commission for diffuse large B-cell lymphoma after initial therapy.
Pfizer provides latest update on oral GLP-1 receptor agonist Danuglipron.
Mirum Pharma's Livmarli tablet approved by FDA for cholestatic pruritus in Alagille syndrome.
NEJM publishes clinical details of Larotrectinib for treating TRK fusion cancers.
Amgen's Tarlatamab demonstrates superior overall survival in small cell lung cancer.
NICE UK updates guidance for Crysvita in treating X-linked hypophosphataemia in children and young people.
FDA approves Opdivo and Yervoy combo for first-line treatment of unresectable or metastatic hepatocellular carcinoma.
FDA approves Vyvgart Hytrulo prefilled syringe for treating myasthenia gravis and CIDP. Argenx SE celebrates.
Apellis announces FDA acceptance and priority review of Empaveli for C3G and primary IC-MPGN.
Brainstorm Cell Therapeutics submits IND amendment for Nurown stem cell therapy for ALS to FDA.
European Commission validates Aspaveli for C3G and IC-MPGN treatment. Sobi and Apellis lead the way.
Biosimilar to Eylea approved for wet AMD, diabetic macular edema, and retinal vein occlusions.
Subgroup analysis of Icotrokinra shows promising results in moderate to severe plaque psoriasis.
Teva and Samsung Bioepis announce the availability of Epysqli injection in the United States.
Teva's Ajovy receives FDA filing acceptance for preventing episodic migraines in pediatric patients.
European Commission approves Tivdak for previously treated recurrent or metastatic cervical cancer.
Tonix and Makana team up to combine TNX-1500 with genetically engineered organs for xenotransplantation studies.
Largest real-world study of Fetroja for serious Gram-negative infections presented.
Shockwave Medical enrolls first patient in novel intravascular lithotripsy study.
Opdivo and Yervoy approved for untreated MSI-H or dMMR metastatic colorectal cancer.
Study shows aprocitentan lowers blood pressure and proteinuria in resistant hypertension.
BioMarin announces pivotal data for Palynziq in adolescents with phenylketonuria.
FDA approves updated label for Tryvio, removing REMS requirement.
Palynziq approved to reduce blood phenylalanine levels in adults with PKU.
Cartesian Therapeutics announces 12-month efficacy and safety data for Descartes-08 in MG.
EU approves Datroway for patients with previously treated metastatic HR-positive, HER2-negative breast cancer.
New data highlights Nipocalimab's sustained disease control in adults with generalized myasthenia gravis.
European Commission approves Dyrupeg, a pegylated filgrastim biosimilar by Curateq Biologics and Aurobindo.
Bayer files for approval of Aflibercept 8 mg to treat retinal vein occlusion in the EU.
European Commission approves Rinvoq for treating adults with giant cell arteritis.
Crexont shows significant sleep quality improvements for Parkinson's patients in Phase III study.
Kaftrio combination regimen approved for cystic fibrosis treatment by European Commission.
Darzalex-based regimen approved for newly diagnosed multiple myeloma patients, regardless of transplant eligibility.
Tonix Pharmaceuticals presents TNX-102 SL treatment effects on fibromyalgia at AAPM 2025.
Sobi gains exclusive rights to commercialize Olezarsen outside the U.S., Canada, and China.
Relacorilant plus nab-paclitaxel meets primary endpoint in platinum-resistant ovarian cancer trial.
Phase II trial shows lorundrostat effective in uncontrolled and resistant hypertension.
Concentra Biosciences acquires Allakos, expanding its biopharmaceutical portfolio.
Tremfya significantly reduces signs, symptoms, and structural damage in psoriatic arthritis.
EU approves Imfinzi-based perioperative regimen for resectable non-small cell lung cancer.
Uplizna becomes the first FDA-approved treatment for IgG4-related disease.
EU approves Slenyto for insomnia in children with ADHD, offering a new treatment option.
Enhertu approved in EU as first HER2-directed therapy for HR-positive, HER2-low breast cancer.
Pacira Biosciences announces the first patient dosed in Phase II study of PCRX-201 for osteoarthritis of the knee.
Aldeyra Therapeutics receives a complete response letter for the resubmission of Reproxalap for dry eye disease.
Roche provides an update on the Phase III study of high-dose Ocrevus in patients with relapsing multiple sclerosis.
Rilzabrutinib receives orphan drug designation in the US for warm autoimmune hemolytic anemia and IgG4-related disease.
NICE UK does not recommend Xenpozyme for treating acid sphingomyelinase deficiency in Niemann-Pick disease.
NICE UK halts appraisal of Onivyde for untreated metastatic pancreatic cancer in combination therapy.
NICE UK endorses Altuvoct for treating and preventing bleeding episodes in patients with Hemophilia A.
Relovair initiates Phase III clinical trial to evaluate its efficacy and safety in treating asthma.
FDA grants accelerated approval for Vanrafiaatrasentan to reduce proteinuria in adults with primary IgA nephropathy.
12-month effectiveness and safety data from SmartFire study presented at 2025 EHRA Congress by Johnson & Johnson MedTech.
Latest heart disease treatment advancements with Impella highlighted at ACC.25 by Johnson & Johnson MedTech.
Merck KGaA secures worldwide commercialization rights for Pimicotinib from Abbisko.
European Commission approves Abrysvo to protect adults 18-59 against RSV lower respiratory tract disease.
Ozempic 1.0 mg boosts walking distance and life quality in type 2 diabetes and PAD at ACC 2025.
Eton Pharmaceuticals out-licenses international rights to Increlex.
Moderna's RSV vaccine for older adults receives approval from Australian Therapeutic Goods Administration.
Daiichi Sankyo initiates Phase III trial of Enhertu for untreated HER2+ advanced gastric cancer.
Winrevair's sotatercept reduces PAH risks by 76% in Phase III Zenith trial, Merck Inc.
Alnylam presents Phase III Helios-B study data on vutrisiran for ATTR-CM at ACC 2025.
Bluebird Bio receives an acquisition offer from Ayrmid Ltd, signaling potential changes in the company's future.
BeiGene's Tevimbra receives positive CHMP opinion as a first-line treatment for extensive-stage small cell lung cancer.
Lepodisiran reduces lipoprotein(a) levels by nearly 94% in adults with elevated levels, showing promising results.
Tremfya receives positive CHMP opinion for treating moderately to severely active Crohn's disease.
Positive CHMP opinion for Opdivo subcutaneous formulation across multiple solid tumor indications.
Santen's Ryjunea gains positive CHMP opinion for slowing the progression of pediatric myopia.
EMA concludes review of Mysimba, a weight management medicine combining naltrexone and bupropion.
TriClip system offers substantial and sustained improvements in tricuspid regurgitation severity after two years.
Bosulif receives positive CHMP opinion to extend its use to children aged 6 years and older.
Qoyvolma, a ustekinumab biosimilar, gains positive CHMP opinion for treating plaque psoriasis.
CHMP recommends Calquence plus chemoimmunotherapy for approval as the first BTK inhibitor for mantle cell lymphoma.
Imfinzi becomes the first perioperative immunotherapy approved in the US for muscle-invasive bladder cancer.
Osvyrti, a denosumab biosimilar, receives positive CHMP opinion for treating osteoporosis and bone loss.
Jubereq, a denosumab biosimilar, gains positive CHMP opinion for preventing skeletal events in advanced malignancies.
Evolut TAVR system demonstrates durable outcomes and excellent valve performance in low-risk aortic stenosis patients.
