Why MaaT Pharma’s MaaT013 survival signal could reshape refractory GI-aGvHD treatment debate
MaaT Pharma’s MaaT013 posted pivotal Phase 3 GI-aGvHD data. Read what it could mean for EMA approval, adoption, and microbiome therapeutics.
Pharma & Biotech
Pharma & Biotech
Sesh Products clears PMTA filing threshold as FDA substantive review begins
Sesh Products' 64-SKU nicotine pouch PMTA enters FDA substantive scientific review. Analysis of what this means for independent pouch brands. Read more.
Pharma & Biotech
Gilead targets durable autoimmune remission with $2.18bn Ouro Medicines acquisition
Gilead Sciences acquires Ouro Medicines for up to $2.18bn, adding BCMA T cell engager gamgertamig to its inflammation pipeline. Analysis of what the deal reveals.
Pharma & Biotech
What Celosia Therapeutics’ Phase 1b CTx1000 trial could reveal about TDP-43 targeting in ALS
Celosia Therapeutics has dosed the first ALS patient with CTx1000. Read why this TDP-43 gene therapy trial could reshape the ALS pipeline.
Pharma & Biotech
Extended-interval nAMD therapy gets a new contender as Innovent Biologics posts Phase 3 STAR data
Innovent Biologics’ efdamrofusp alfa cleared a key Phase 3 nAMD hurdle in China. Read what the STAR data could change for retinal treatment.
Pharma & Biotech
Can Prestige Biopharma turn HD204 Phase 3 data into a credible Avastin biosimilar launch?
Prestige Biopharma reported positive HD204 Phase 3 data in NSCLC. Read what the bevacizumab biosimilar result could change next.
Pharma & Biotech
Theriva Biologics leverages FDA and EMA feedback to optimize VCN-01 pivotal trial
Theriva Biologics advances VCN-01 into phase 3 for metastatic pancreatic cancer with FDA and EMA guidance. Explore trial design, dosing strategy, and risks.
Pharma & Biotech
Avalyn Pharma moves AP02 into Phase 2, exploring whether nebulized delivery can improve risk benefit balance in IPF
Avalyn Pharma advances inhaled AP02 into Phase 2 trials for IPF. Learn how lung targeted delivery could reshape antifibrotic treatment.
Pharma & Biotech
Harbour BioMed HBM9378 Phase I data: does long-acting TSLP inhibition change asthma treatment economics?
Harbour BioMed’s HBM9378 Phase I data shows long half-life and safety. Find out what this means for asthma, COPD, and TSLP competition.
Pharma & Biotech
Dizal’s Zegfrovy challenges chemo dominance in rare EGFR lung cancer mutation
Zegfrovy Phase 3 results could redefine EGFR exon20ins lung cancer treatment. Discover what this means for frontline therapy and future care strategies.