Teleflex to acquire Biotronik's vascular intervention business, expanding their medical device portfolio.
Phase II trial of Ziftomenib shows positive results in patients with relapsed/refractory NPM1-mutant AML.
EMA approves subcutaneous Takhzyro (lanadelumab) for recurrent hereditary angioedema attacks.
FDA accepts sBLA for Gamifant (emapalumab) for treating macrophage activation syndrome in adults and children.
JAMA publishes results of Versamune HPV, PDS01 ADC, and PD-L1 inhibitor combo for HPV-associated cancers.
Eli Lilly acquires FXR 314 program from Organovo Holdings Inc. to enhance its drug pipeline.
Bayer's Gadoquatrane shows positive results in Phase III study for investigational contrast agent.
NDA submitted to FDA for Plozasiran to treat familial chylomicronemia syndrome by Arrowhead Pharmaceuticals.
MHLW Japan approves additional dosage of Canalia combination tablets for type 2 diabetes.
FDA approves label changes for Sublocade, including rapid initiation and alternative injection sites.
FDA approves Vimkunya vaccine for Chikungunya for persons aged 12 and older by Bavarian Nordic.
FDA grants priority review for Keytruda plus standard care for advanced head and neck cancer.
European Commission approves Eydenzelt and Stoboclo biosimilars referencing Prolia and Xgeva.
European Commission grants marketing authorization for Avtozma, a biosimilar referencing RoActemra.
NMPA China approves Vibativ injection for severe bacterial infections by SciClone and Cumberland Pharma.
European Commission approves Nemluvio for moderate to severe atopic dermatitis and prurigo nodularis.
MHRA UK and Swissmedic approve Nemolizumab for atopic dermatitis and prurigo nodularis.
New vial sizes and pricing for self-pay patients
NGM Bio doses first patient in EMERALD Phase II study of NGM120 for treating hyperemesis gravidarum.
FDA accepts sBLA for Opdivo and Yervoy in treating unresectable or metastatic colorectal cancer.
EMA validates MAA for twice-yearly lenacapavir by Gilead Sciences for HIV prevention.
FDA approves Ctexli (chenodiol) tablets for treating cerebrotendinous xanthomatosis in adults.
andoz launches biosimilar Pyzchiva (ustekinumab) in the US, offering new treatment for 1.2 million patients.
FDA grants priority review to Boehringer's Zongertinib for HER2/ERBB2 mutant advanced non-small cell lung cancer.
Boehringer's Nerandomilast BI 1015550 meets primary endpoint in Phase III study for progressive pulmonary fibrosis.
NICE UK approves Retevmo (selpercatinib) for RET fusion-positive advanced non-small cell lung cancer by Eli Lilly.
Sanofi and Teva present new Duvakitug data at ECCO, showing promise in ulcerative colitis and Crohn's disease.
Bluebird bio, a pioneering gene therapy developer, agrees to be acquired and taken private by Carlyle Group and SK Capital. This move aims to stabilize the company's financial struggles and unlock its full potential.
Pfizer terminates the development and commercialization of its hemophilia B gene therapy, Beqvez (fidanacogene elaparvovec), globally. Regulatory filings in Japan are withdrawn, and appraisals in the UK are suspended.
Johnson & Johnson's Tremfya (guselkumab) shows promising results for both intravenous and subcutaneous induction therapy in ulcerative colitis. Learn more about the ASTRO study findings and their impact on UC treatment.
Teva and Alvotech launch Selarsdi, a biosimilar to Stelara, in the USA. Approved by the FDA for multiple autoimmune conditions, Selarsdi offers a cost-effective treatment option.
Seladelpar granted conditional European marketing authorization for the treatment of primary biliary cholangitis by Gilead Sciences. Learn more about this significant milestone in PBC treatment.
AstraZeneca completes acquisition of FibroGen China, expanding its presence in the Chinese market.
MHLW Japan approves CSL Behring's Andembrygaradacimab for preventing acute hereditary angioedema attacks.
Results of Phase 1b ARC-20 trial of casdatifan in metastatic ccRCC patients after prior therapies presented at ASCO GU 2025.
FDA issues refusal to file letter for Harmony Biosciences' pitolisant for excessive daytime sleepiness in idiopathic hypersomnia.
GSK's Nucala (mepolizumab) application for COPD accepted for review in China.
European Commission approves Obodence and Xbryk, denosumab biosimilars referencing Prolia and Xgeva by Samsung Bioepis.
DA approves Ospomyv and Xbryk, denosumab biosimilars referencing Prolia and Xgeva by Samsung Bioepis.
EC validates Aspaveli extension for C3 glomerulopathy treatment. Sobi and Apellis lead the initiative.
FDA approves Merilog, the first rapid-acting insulin biosimilar for diabetes treatment by Sanofi.
Merck's Welireg receives first EC approval for two indications, marking a significant milestone.
Final analysis of CheckMate-816 shows overall survival benefits of Opdivo with chemotherapy for NSCLC.
AskBio's investigational gene therapy for Parkinson's disease receives FDA regenerative medicine designation.
FDA accepts new drug applications for twice-yearly Lenacapavir for HIV prevention under priority review.
Nippon Boehringer Ingelheim submits NDA for Zongertinib to treat HER2-positive advanced NSCLC in Japan.
Bayer's new data confirms safety and improved efficacy of Darolutamide in metastatic hormone-sensitive prostate cancer.
Ultragenyx's UX111 gene therapy for MPS IIIA receives FDA acceptance and priority review.
FDA accepts BLA for AVT-06, a proposed biosimilar to Eylea, for treating eye disorders.
European Commission approves Emcitate (tiratricol) for treating monocarboxylate transporter 8 (MCT8) deficiency. Egetis Therapeutics.
First participant randomized in Europe for Phase II gene therapy trial of AB-1002 for congestive heart failure. AskBio & Bayer.
Romvimza (vimseltinib) approved by FDA for adults with symptomatic tenosynovial giant cell tumor (TGCT). Details inside.
Penmenvy approved by FDA to protect against MenABCWY meningococcal disease. Learn more about GSK's new vaccine.
Immedica completes acquisition of Marinus Pharmaceuticals, expanding its portfolio in rare diseases.
Imfinzi lowers risk of distant metastases and death in bladder cancer compared to neoadjuvant chemotherapy alone.
Relativity-098 trial did not meet primary endpoint of recurrence-free survival in stage III-IV melanoma.
New data confirms Sotyktu's consistent safety and durable response in moderate-to-severe plaque psoriasis.
Phase III CheckMate-9ER trial shows Cabometyx and Opdivo's efficacy over sunitinib in treating renal cell carcinoma.
Novo Nordisk's Ozempic (semaglutide) shows promise in Phase II trial for treating alcohol use disorder (AUD).
Pfizer's combination therapy with Talzenna and Xtandi improves survival outcomes in metastatic prostate cancer.
Bayer files for approval of Finerenone in Japan, aiming to treat heart failure and improve patient outcomes.
European Commission approves Kostaive (ARCT-154), a self-amplifying mRNA COVID-19 vaccine by CSL and Arcturus Therapeutics.
FDA extends approval for Astellas' Izervay (avacincaptad pegol) without dosing duration limits for geographic atrophy.
European Commission approves Andembry (garadacimab) to prevent hereditary angioedema attacks in patients 12+
FDA approves Adcetris (brentuximab vedotin) combination for treating relapsed/refractory diffuse large B-cell lymphoma.
Two-year data at EHSF 2025 shows Bimzelx (bimekizumab) provides sustained disease control in hidradenitis suppurativa.
FDA approves Evrysdi (risdiplam) tablet, the first and only tablet for spinal muscular atrophy, by Genentech/Roche.
FDA approves Gomekli (mirdametinib) for treating neurofibromatosis type 1 with symptomatic plexiform neurofibromas.
ALTO-300 shows favorable outcomes in Phase IIb trial for major depressive disorder, reports Alto Neuroscience.
NICE endorses Lynparza for BRCA mutation-positive, HER2-negative advanced breast cancer post-chemotherapy.
Zongertinib being evaluated in BEAMion Phase II trial for NSCLC with HER2 tyrosine kinase domain mutations.
FDA accepts New Drug Application for Troriluzole to treat adult patients with spinocerebellar ataxia.
Padcev and Keytruda demonstrate long-term efficacy in first-line treatment of advanced urothelial cancer.
Hansizhuang with chemotherapy approved by EC as first-line treatment for small cell lung cancer in adults.
European Commission approves Beyonttra for treating transthyretin amyloidosis with cardiomyopathy in adults.
Novartis acquires Anthos Therapeutics, gaining abelacimab for potential cardiovascular treatments.
Bayer confirms long-term efficacy and safety of Eylea 8 mg with extended dosing intervals in wet AMD.
First cohort B patient completes dosing in TCB-008 Phase IIb trial for acute myeloid leukemia.
Novo Nordisk's weekly Mim8 shows efficacy and safety in children with hemophilia A, with and without inhibitors.
Eton Pharmaceuticals announces PDUFA goal date extension for ET-400 for adrenal insufficiency.
BMS reports positive topline results for Breyanzi in relapsed/refractory marginal zone lymphoma.
KalVista presents new data on sebetralstat for hereditary angioedema at WSAAI 2025 Annual Meeting.
Phase III STAAR study data supports isaralgagene civaparvovec as a treatment for Fabry disease.
AIM ImmunoTech commentary on study linking COVID-19 to chronic fatigue syndrome.
Globus Medical announces acquisition of Nevro Corp, expanding its global footprint in the medical device industry.
AbbVie's Emblaveo (aztreonam and avibactam) receives FDA approval for treating complicated intra-abdominal infections.
Astellas submits Avacincaptad Pegol to Japan's MHLW for treating geographic atrophy secondary to AMD.
FDA accepts revised sNDA for Astellas' Izervay (avacincaptad pegol) to treat geographic atrophy secondary to AMD.
New England Journal of Medicine publishes data showing Gazyva's superiority over standard therapy in active lupus nephritis.
Alumis Inc. announces merger with Acelyrin Inc., aiming to enhance their combined capabilities in biopharmaceuticals.
NICE UK gives positive recommendation for Orserdu (elacestrant) to treat advanced breast cancer with ESR1 mutation.
Eli Lilly's Omvoh (mirikizumab) achieves sustained clinical remission and endoscopic response in Crohn's disease over two years.
Four-year HOPE-B study results confirm Hemgenix's durability and safety as a one-time infusion for Hemophilia B.
Merck initiates Phase III WAVeLINE-010 trial for Zilovertamab Vedotin in untreated diffuse large B-cell lymphoma patients.
Recursion's Phase II Sycamore study shows promising 12-month data for REC-994 in treating cerebral cavernous malformations.
Immvention Therapeutix and Novo Nordisk team up to develop innovative treatments for sickle cell disease.
MHRA UK approves Valneva's Ixchiq, a new vaccine for chikungunya, marking a significant medical advancement.
Annovis Bio initiates Phase III trial for Buntanetap in early Alzheimer's, aiming to advance treatment options.
Ultragenyx's new data shows promising results for UX-111 in treating Sanfilippo Syndrome Type A (MPS IIIA).
Cumberland Pharma's Ifetroban shows positive results in Phase II trial for Duchenne Muscular Dystrophy heart disease.
FDA approves Susvimo (ranibizumab) injection for treating diabetic macular edema. Learn more about Roche's new treatment.
FDA approves Onapgo (apomorphine) injection for treating motor fluctuations in advanced Parkinson's disease. Discover more from Supernus Pharma.
CHMP gives positive opinion for Imfinzi to treat limited-stage small cell lung cancer post-chemoradiation.
European commission approves blincyto blinatumomab monotherapy for newly diagnosed philadelphia chromosome negative cd19 positive b cell precursor acute lymphoblastic leukemia
Bayer files for EU approval of finerenone for treating heart failure.
Braftovi (encorafenib) combo significantly improves progression-free and overall survival in Phase III trial.
Roche's HER2 ultralow diagnostic gets FDA approval for identifying patients eligible for Enhertu.
Nab-paclitaxel with gemcitabine and cisplatin shows no significant survival benefit in biliary cancer.
177Lu-Edotreotide shows extended progression-free survival in gastro-enteropancreatic neuroendocrine tumors.
NMPA China approves Isatuximab combo for newly diagnosed multiple myeloma.
FDA approves Avtozma Tocilizumab as a biosimilar to Actemra in IV and SC forms.
CHMP positive for Rystiggo rozanolixizumab to be administered via infusion syringe pump or new manual push syringe method.
European Commission authorises Vocabria cabotegravir and Rekambys rilpivirine long-acting injections for HIV-1 treatment in adolescents.
Positive CHMP opinion for Opdivo nivolumab plus Yervoy ipilimumab as first-line treatment for advanced hepatocellular carcinoma.
Positive CHMP opinion for CAR-T cell therapy Breyanzi lisocabtagene maraleucel for relapsed or refractory follicular lymphoma.
Positive CHMP opinion for Capvaxive pneumococcal 21-valent conjugate vaccine for pneumococcal vaccination in adults.
FDA approves Symbravo meloxicam and rizatriptan for acute treatment of migraine with or without aura in adults.
CHMP recommends Tivdak tisotumab vedotin to treat recurrent or metastatic cervical cancer.
CHMP recommends Pavblu aflibercept biosimilar intended for AMD, RVO, DME, and myopic CNV.
Datopotamab deruxtecan recommended for approval in the EU by CHMP for previously treated metastatic HR-positive HER2-negative breast cancer.
Update on regulatory review of lecanemab for early Alzheimer's disease in the European Union by Eisai and Biogen.
CHMP recommends Vimkunya CHIKV VLP vaccine for immunization to prevent disease caused by chikungunya virus in individuals 12 years and older.
Tropion-Lung12 Phase III trial initiated evaluating Datroway datopotamab deruxtecan for early-stage non-small cell lung cancer at high risk of relapse.
FDA approves Journavx suzetrigine, an oral non-opioid highly selective Nav1.8 pain signal inhibitor for moderate to severe acute pain in adults.
