Prostate-specific antigen level should be assessed for at least 3 months after radical prostatectomy to minimize overtreatment, research shows.
A meta-analysis reveals that tacrolimus significantly improves symptoms and MG-related scores in patients with juvenile MG (JMG).
US court upholds Eisai’s Lenvima patent, blocking Shilpa’s generic until 2036; key IP win in oncology portfolio.
Moderna’s H5 flu vaccine shows strong immune response in Phase 1/2; HHS ends late-stage funding, new paths explored.
Daiichi Sankyo & Merck withdraw patritumab deruxtecan BLA after HERTHENA-Lung02 OS data miss significance.
FDA expands MenQuadfi use to infants 6 weeks+, making it the only MenACWY vaccine approved across all age groups.
FDA approves Khindivi, the first oral hydrocortisone solution for kids 5+ with adrenal insufficiency—no mixing required.
CC-42344 shows potent activity vs H5N1 avian flu, 1,000× stronger than Tamiflu in vitro; targets conserved PB2 site.
Keros ends TROPOS trial of cibotercept in PAH after safety concerns; strategic review underway for future development.
FDA outlines path for elamipretide in Barth syndrome after AdCom vote; accelerated approval may follow NDA resubmission.
Qualitative study suggests that weakness and fatigue are the top treatment priorities for people with CIDP.
Lilly acquires SiteOne and STC-004, a Nav1.8 inhibitor, to advance non-opioid pain therapies for chronic pain patients.
Sanofi acquires DR-0201 for $600M upfront; novel bispecific shows promise in B-cell driven autoimmune diseases like lupus.
FDA approves Tendyne, Abbott’s TMVR system, offering a non-surgical option for mitral valve disease with severe MAC.
TARGET study shows MONARCH bronchoscopy reached lung nodules in 98.7% of cases with 83.2% diagnostic yield and safety.
Pfizer and BioNTech submit EMA application for 2025–26 COVID-19 vaccine targeting LP.8.1, a dominant Omicron subvariant.
Pimicotinib shows best-in-class efficacy in TGCT, with strong ORR, pain relief, and improved mobility in Phase III trial.
EC approves subcutaneous Opdivo for solid tumors, offering faster delivery with comparable efficacy to IV form.
PIVOT-PO Phase III trial of tebipenem HBr stopped early for efficacy after IDMC review; GSK and Spero to file NDA in 2025.
Moderna files FDA application for LP.8.1 COVID-19 vaccine, aligning with guidance to target JN.1 lineage for 2025–2026.
Novartis begins tender offer to acquire Regulus, advancing kidney care with farabursen for ADPKD patients.
Global oncology company moves to Switzerland
FDA accepts BLA for sibeprenlimab in IgAN; priority review granted with PDUFA date set for Nov 28, 2025.
RP-A501 trial paused after SAE and patient death; Rocket, FDA, and experts investigating safety in Danon gene therapy study.
NMPA approves Minjuvi + lenalidomide, followed by monotherapy, for adults with relapsed/refractory DLBCL in China.
FDA approves Jivi for kids 7–12 with hemophilia A, based on PROTECT studies showing safety and bleed rate reduction.
CHMP backs Tevimbra plus chemo for first-line NPC, showing strong PFS and OS gains in the RATIONALE-309 Phase III trial.
CHMP adopts positive opinion for Bomyntra and Conexxence, denosumab biosimilars for osteoporosis and bone conditions.
CHMP adopts positive opinion for Rolcya, a denosumab biosimilar, supporting its EU approval for bone-related conditions.
FDA approves Yutrepia for PAH and PH-ILD, offering a dry-powder treprostinil option with improved delivery and tolerability.
CHMP adopts negative opinion on resminostat (Kinselby) for CTCL, halting 4SC AG’s EU approval path for the HDAC inhibitor.
The ACTION study reveals major gaps in obesity care across the U.S., calling for systemic change in treatment approaches.
Prothena’s AFFIRM-AL trial of birtamimab in AL amyloidosis did not meet its primary endpoint in Mayo Stage IV patients.
CHMP recommends Imfinzi as first perioperative immunotherapy for MIBC, showing OS and EFS gains in NIAGARA trial.
CHMP adopts positive opinion for Riulvy in RRMS, supporting Neuraxpharm’s EU approval path for tegomil fumarate.
Medtronic to separate its diabetes business into a standalone company, aiming to boost focus and operational agility.
Regeneron acquires 23andMe assets, including PGS and Biobank, to expand genomic research and health service offerings.
Crescita ends Pliaglis license with Croma, regains rights in key markets, and seeks new partners for commercialization.
Ziftomenib KOMET-001 trial data to be presented at ASCO 2025, highlighting efficacy in NPM1-mutant AML patients.
Innate shares long-term TelloMAK data on lacutamab in Sézary syndrome and MF, showing promise in CTCL treatment.
Servier acquires BN-104, a menin inhibitor in Phase I/II, to expand its leukemia pipeline and address unmet needs.
MHRA approves Akantior (polihexanide) for Acanthamoeba keratitis, offering a licensed option for this rare eye infection.
FDA approves Zoryve foam 0.3% for scalp and body plaque psoriasis in adults and children 12+, offering steroid-free relief.
Servier to acquire BN 104, a Phase I/II menin inhibitor for AML and ALL, expanding its hematology pipeline in R/R settings.
CHMP backs Itovebi + palbociclib/fulvestrant for PIK3CA-mutated ER+/HER2– breast cancer after adjuvant endocrine relapse.
CHMP issues positive opinion for Aucatzyl in adults 26+ with R/R B-ALL. FELIX trial shows strong CR/CRi and MRD response.
FDA approves Nucala for eosinophilic COPD. Phase III trials show reduced exacerbations with add-on subcutaneous therapy.
Two-year STARGLO data show Columvi + GemOx significantly improves OS in R/R DLBCL patients ineligible for transplant.
ARCHES trial shows 5-year survival benefit in mHSPC with ARPI + ADT, reducing death risk by 30% vs. placebo + ADT.
CHMP backs Eylea 8 mg for nAMD and DME with 6-month intervals, based on PULSAR and PHOTON trials showing sustained efficacy.
CHMP issues positive opinion for Maapliv, an IV BCAA-free amino acid solution for acute MSUD episodes from birth.
CHMP issues positive opinion for Blenrep combos in RRMM based on DREAMM-7/8 trials showing PFS and OS benefits.
CHMP issues positive opinion for mirdametinib in NF1-PN. Phase IIb data show durable responses in adults and children.
ASCENT-03 shows Trodelvy significantly improves PFS in first-line mTNBC patients ineligible for checkpoint inhibitors.
Sanofi to acquire Vigil Neuroscience, adding VG 3927—an oral TREM2 agonist for Alzheimer’s—to its neurology pipeline.
Phase II data show 63% ORR with petosemtamab + pembrolizumab in PD-L1+ HNSCC, including complete responses and durability.
FDA approves Susvimo for diabetic retinopathy (DR). Port Delivery System offers sustained vision gains with fewer treatments.
EMPOWER CAD study shows IVL-first PCI strategy improves outcomes in real-world female patients with calcified lesions.
FDA panel votes 6–2 for Darzalex Faspro in high-risk smoldering myeloma, supporting early intervention via AQUILA study.
China approves Eylea 8 mg for wet AMD based on PULSAR trial, enabling extended dosing with sustained visual outcomes.
Post-hoc AURORA 1 data show Lupkynis-based triple therapy achieves deeper proteinuria reduction in lupus nephritis.
Prompt TAVR in severe aortic stenosis reduces healthcare costs and improves outcomes, per Edwards Lifesciences data.
Sandoz launches Pyzchiva autoinjector, Europe’s first ustekinumab biosimilar device, for chronic inflammatory diseases.
ESSENCE study: Olezarsen (Tryngolza) shows 61% TG reduction in ASCVD-risk patients with moderate hypertriglyceridemia.
Moderna withdraws BLA for mRNA-1083 flu/COVID-19 combo vaccine; plans resubmission post mRNA-1010 Phase III data.
J&J MedTech launches Soundstar Crystal catheter in US, enhancing 2D ICE imaging and workflow in cardiac ablation.
NICE backs Truqap + fulvestrant for HR+/HER2- advanced breast cancer post-endocrine therapy in select genetic profiles.
FDA panel voted 4–5 on UGN-102 benefit/risk for recurrent LG-IR-NMIBC; NDA under review with June 13 PDUFA date.
WILLOW study: enpatoran showed dose-dependent CLASI-A improvements in CLE/SLE with lupus rash; well-tolerated profile.
FDA panel reviews Columvi + GemOx for R/R DLBCL; STARGLO trial shows 41% OS benefit vs R-GemOx in transplant-ineligible patients.
AstraZeneca finalizes $1B acquisition of EsoBiotec, gaining ENaBL platform to advance in vivo cell therapy delivery.
Early, sustained TTR rise with acoramidis linked to improved survival in ATTR-CM, per ATTRibute-CM Phase III data.
Rademikibart improved FEV₁ within 24h and reduced exacerbations in asthma; data support Phase 2 COPD trials.
Pfizer pays $1.25B upfront to 3SBio
Acoramidis reduced AF-related hospitalizations by 43% and new-onset AF by 17% in ATTR-CM patients vs placebo.
NICE recommends Ontozry (cenobamate) for adults with drug-resistant focal-onset seizures after 2 failed therapies.
NICE recommends Balversa for FGFR3+ unresectable/metastatic urothelial cancer post PD-1/PD-L1 inhibitor in UK adults.
NICE recommends osimertinib with pemetrexed and platinum chemo for untreated EGFR+ advanced NSCLC in UK adults.
NICE recommends Adcetris with chemo for untreated stage 3/4 CD30+ Hodgkin lymphoma, offering a new frontline option.
NICE ends Skyclarys appraisal for Friedreich’s ataxia as Biogen withdrew evidence; no UK recommendation issued.
Early, sustained TTR rise with acoramidis linked to 31.6% lower mortality in ATTR-CM, per ATTRibute-CM Phase III data.
BATURA trial shows Airsupra reduces severe asthma exacerbations by 47%, supporting its use as rescue therapy in mild cases.
Phase III trials show nerandomilast slows lung function decline in IPF and PPF with placebo-like discontinuation rates.
FDA approves Nuvaxovid for adults 65+ and high-risk 12–64s, marking first full U.S. license for a protein-based COVID-19 vaccine.
FDA grants full approval to Novavax’s protein-based COVID-19 vaccine for adults 65+ and high-risk 12–64s; postmarketing trial required.
Daiichi Sankyo and Merck launch Phase III trial of ifinatamab deruxtecan in advanced ESCC after platinum and checkpoint therapy.
FDA extends PDUFA date to Q4 2025
HELIOS-B trial shows Amvuttra cut death and CV events by 28–36% in ATTR-CM, with added benefits on function and QoL.
Japan approves Blenrep with BVd or BPd for relapsed/refractory myeloma after DREAMM-7/8 trials show superior survival and response.
FDA approves Brekiya, the first DHE autoinjector for migraines and cluster headaches, offering fast, self-administered relief.
Phase III trial of Iontak (E7777) shows strong response in CTCL with no new safety signals, supporting BLA submission by Citius.
FDA approves Novavax’s protein-based COVID-19 vaccine for adults 65+ and at-risk 12–64s, with postmarketing trial required.
BioMarin to acquire Inozyme for $270M, adding INZ-701, a Phase 3 enzyme therapy for ENPP1 deficiency, to its rare disease pipeline.
Jury finds Amgen violated antitrust laws by bundling Repatha with unrelated drugs, awarding Regeneron $407M in damages.
First plasma test for amyloid pathology
Phase 3 data show Crenessity reduces glucocorticoid use and improves hormone levels in CAH patients, per AACE 2025 results.
Phase 4 data show Ingrezza improves function and quality of life in tardive dyskinesia, per ISPOR 2025 findings by Neurocrine.
EU approves Opdivo plus chemo before and after surgery for PD-L1+ NSCLC, cutting recurrence risk by 42% in CheckMate-77T.
Mallinckrodt shares real-world data showing 89% of lupus patients improved with Acthar Gel; 44% reduced steroid use.
NEJM publishes Phase 2b data on TAK-861 for narcolepsy type 1, showing major gains in wakefulness and reduced cataplexy.
MHRA approves Tepezza as UK’s first targeted treatment for moderate-to-severe thyroid eye disease in adults, says Amgen.
Novo Nordisk and Septerna partner to develop oral small molecules for obesity and diabetes, in a $2.2B GPCR-focused deal.
FDA approves Zynyz with chemo or alone for advanced anal cancer, showing improved survival in pivotal POD1UM trials.
FDA approves Emrelis for advanced NSCLC with high c-Met overexpression after prior therapy; based on LUMINOSITY trial.
FDA approves Welireg for adults and children 12+ with advanced PPGL, offering first oral treatment for rare tumors.
FreeStyle Libre CGM linked to fewer heart-related hospitalizations in diabetes, per REFLECT study findings.
In KEYNOTE-B96, Keytruda + chemo met PFS endpoint in platinum-resistant recurrent ovarian cancer, with OS benefit in PD-L1+ patients.
Alnylam to present new HELIOS-B Phase III analyses at Heart Failure 2025, detailing vutrisiran’s impact on mortality and hospitalization in ATTR-CM.
FDA approves Roche’s VENTANA MET (SP44) RxDx Assay as first companion diagnostic to identify NSCLC patients eligible for Emrelis.
GSK to acquire efimosfermin for $2B to treat steatotic liver disease. Phase III-ready FGF21 analog shows antifibrotic potential.
FDA accepts BLA for RGX-121 (clemidsogene lanparvovec) with Priority Review for MPS II, a potential one-time gene therapy.
iTeos and GSK terminate belrestotug development after Phase 2 trials failed to meet efficacy goals in lung and head & neck cancers.
First asymptomatic participant with a TTR variant dosed in ACT-EARLY, marking a milestone in ATTR prevention with acoramidis.
In MAPLE-HCM Phase III, aficamten showed superior improvement in peak oxygen uptake vs. metoprolol in HCM patients.
Tremfya (guselkumab) approved in EU as first IL-23 inhibitor with IV and SC induction for moderate-to-severe Crohn’s disease.
BridgeBio doses first participant in ACT-EARLY, the first ATTR prevention study using acoramidis in asymptomatic TTR variant carriers.
Ten-year APHINITY data show Perjeta-based regimen reduced death risk by 17% in HER2+ early breast cancer, per Roche.
In SURMOUNT-5, Zepbound (tirzepatide) led to 20.2% weight loss vs. 13.7% with Wegovy (semaglutide), showing clear superiority.
Trixeo Aerosphere approved in UK as first inhaled respiratory drug with near-zero global warming propellant.
Voxzogo (vosoritide) shows reduced tibial bowing in achondroplasia and early efficacy in other skeletal disorders, per new studies.
A Danish trial shows that alternating the XBCM test with cystoscopy in high-grade bladder cancer follow-up cut the use of cystoscopies by 55%.
First-line axicabtagene ciloleucel (axi-cel) shows high rates of complete and durable responses in high-risk large B-cell lymphoma (LBCL).
BioMarin presents new data on Voxzogo for children with achondroplasia at international endocrinology meetings.
Valneva updates recommended use of Ixchiq for elderly individuals in the US, enhancing safety and efficacy.
Novo Nordisk's Sogroya shows efficacy and tolerance in children with growth disorders, presented at ESPE and ESE Congress.
Icotrokinra shows significant skin clearance in scalp and genital psoriasis patients, offering a promising new treatment option.
Imfinzi plus BCG therapy significantly improves disease-free survival in high-risk NMIBC patients, per POTOMAC Phase III trial results.
FDA approves Avmapki (Fakzynja co-pack) for KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC).
Bayer submits aflibercept 8 mg for approval in Japan to treat macular edema following retinal vein occlusion.
Merit Medical releases 12-month efficacy results for the single-arm arteriovenous graft cohort of the Wrapsody trial.
Rystiggo (rozanolixizumab) receives approval in Japan for two new administration methods for generalized myasthenia gravis (GMG).
GSK's Phase III GLISTEN trial results show linerixibat significantly improves cholestatic pruritus in primary biliary cholangitis (PBC).
Shionogi to acquire Japan Tobacco's pharmaceutical operations, including Torii Pharmaceutical, expanding its healthcare portfolio.
Crenessity (crinecerfont) reduces glucocorticoid dosing and maintains androstenedione levels in pediatric CAH, per Phase III study.
Valneva's Ixchiq approved by EMA for use in elderly patients to prevent chikungunya fever, enhancing protection for this age group.
Positive Phase IIa trial data for MAR-001 presented at EAS Congress, showing promise in treating residual cardiovascular risk.
Iqirvo (elafibranor) reduces fatigue and provides anti-inflammatory benefits in PBC patients, per late-breaking exploratory data.
Daratumumab significantly reduces disease progression risk and improves survival in people with high-risk SMM, compared with active monitoring.
MINT trial: Inebilizumab significantly reduces disease severity in people with generalized myasthenia gravis compared with placebo.
Findings suggest that children exhibiting more severe symptoms during the first week of an AU episode may be at increased risk of developing CSU.
News article on phase 3 data of tolebrutinib compared with placebo and teriflunomide in multiple sclerosis from HERCULES, GEMINI 1, and GEMINI 2.
Study suggests that thrombotic events, acute kidney injury, and hemolytic events are rare among people with CIDP receiving IVIg.
API-CAT: Extended anticoagulation with reduced-dose apixaban results in similar VTE risk and reduced bleeding risk in patients with CAT.
Top-line data from OSPREY trial shows Aura 6000 system effective in treating moderate to severe obstructive sleep apnea.
Phase II results show bemnifosbuvir and ruzasvir effective in treating hepatitis C virus, offering promising new treatment options.
Final Phase III MYR301 study data shows longer Hepcludex (bulevirtide) treatment sustains undetectability in chronic HDV.
Livdelzi (seladelpar) shows consistent efficacy and safety in PBC patients, regardless of prior treatment history, per new EASL data.
Enhertu (trastuzumab deruxtecan) followed by THP before surgery shows significant response in high-risk HER2+ breast cancer.
ALXN-1840 shows promising long-term efficacy and safety for Wilson disease, presented at EASL meeting by Monopar Therapeutics.
FDA accepts resubmission of Narsoplimab BLA for TA-TMA treatment; PDUFA date set for end of September 2025 by Omeros Corporation.
Genmab to submit supplemental BLA to FDA for Epcoritamab plus R2 in relapsed/refractory follicular lymphoma patients.
Sangamo announces key derisking events for planned BLA submission of ST-920 to treat Fabry disease, advancing its pathway.
FDA grants Fast Track designation to Givinostat (Duvyzat) for treating polycythemia vera, announced by Italfarmaco.
Calquence plus chemoimmunotherapy approved in EU as first BTK inhibitor for 1st-line mantle cell lymphoma by AstraZeneca.
Roche launches Elecsys Pro-C3 test to enhance precision in assessing liver fibrosis severity, offering innovative solutions.
Reproxalap achieves primary endpoint in Phase III dry eye disease trial; NDA resubmission planned by Aldeyra.
PTC-518 achieves primary endpoint in Stage 2 and Stage 3 Huntington's disease study, announced by PTC Therapeutics.
TPM-502 nanoparticles coupled with CED antigens show positive proof-of-concept in celiac disease, by Topas Therapeutics.
New survey highlights the need for routine screening and earlier diagnosis for people living with tardive dyskinesia, by Neurocrine Biosciences.
Updated Phase 1b/2 trial results show Epcoritamab combo's efficacy in relapsed/refractory follicular lymphoma, by AbbVie.
FDA approves Selarsdi (ustekinumab-aekn) as interchangeable with Stelara for treating multiple inflammatory conditions.
Celldex announces ongoing Phase II data for barzolvolimab in eosinophilic esophagitis, showing promising results.
FDA lifts clinical hold on Ebvallo (tabelecleucel) IND applications, allowing Atara to resume trials for EBV+ PTLD.
Tremfya (guselkumab) positioned as the first IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis, per new data.
Tremfya (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis patients over two years.
FDA issues a complete response letter for TLX101 (18F-FET Pixclara) for glioma imaging, requiring further data.
FDA grants approval for Tepylute, a ready-to-dilute thiotepa formulation, to treat breast and ovarian cancer.
FDA approves Sapien 3 TAVR for severe aortic stenosis in asymptomatic patients, expanding treatment options.
Immunic's vidofludimus calcium shows positive Phase II results in progressive multiple sclerosis, reducing disability.
BriaCell reports positive tolerability and potential response biomarkers in Phase III data for metastatic breast cancer at AACR 2025.
NICE updates recommendations for Paxlovid, sotrovimab, and tocilizumab in treating COVID-19, reflecting new evidence and pricing changes.
AstraZeneca's Breztri (budesonide/glycopyrronium/formoterol fumarate) meets primary endpoints in Phase III KALOS and LOGOS trials for asthma.
FDA extends PDUFA date for Cytokinetics' aficamten in obstructive hypertrophic cardiomyopathy to December 26, 2025.
MHRA authorizes Vimkunya vaccine for preventing chikungunya virus in people aged 12 and older in the UK.
Abivax completes Phase III ABTECT trials enrollment for moderately to severely active ulcerative colitis, with top-line results expected in Q3 2025.
Nucala (Mepolizumab) significantly reduces COPD exacerbations in MATINEE trial, published in NEJM, showing promising results.
Novartis to acquire Regulus Therapeutics, advancing kidney care with farabursen, a promising treatment for ADPKD.
Cytisinicline Phase III ORCA-3 trial shows promise for smoking cessation, reducing cravings and boosting quit rates.
Atzumi nasal powder earns FDA approval, offering a convenient and effective option for acute migraine treatment.
Neurocrine begins Phase III trial for NBI-1117568, a muscarinic M4 agonist, aiming to treat schizophrenia effectively.
Imaavy (nipocalimab-aahu) earns FDA approval as a new FcRn blocker, offering lasting disease control for GMG patients.
Zevaskyn earns FDA approval as the first gene therapy for RDEB, offering hope for healing and pain relief.
lkermes survey reveals challenges in AUD diagnosis and highlights the positive impact of treatment on recovery journeys.
Sandoz partners with Henlius to commercialize ipilimumab biosimilar, expanding global access to advanced cancer therapies.
Rinvoq (upadacitinib) gains FDA approval as the first oral treatment for giant cell arteritis, offering new hope for patients.
