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GSK's Wellcovorin (leucovorin) wins FDA approval for cerebral folate deficiency targeting folate receptor 1
Small molecule, neurological, folate deficiency, cerebral folate deficiency, FOLR1 gene, autism spectrum disorder - Read more

Idorsia, Pharmalink partner on QUVIVIQ distribution across UAE and Gulf states with upfront payment
Distribution agreement, neurological, commercialization, small molecule - Read more

Prothena and Novo Nordisk achieve Ph3 enrollment milestone for coramitug in ATTR amyloidosis with cardiomyopathy
Antibody, cardiovascular, monoclonal antibody, ATTR amyloidosis, amyloid depleter, cardiomyopathy - Read more

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Ascletis Pharma's ASC30 GLP-1 depot injection shows sustained weight loss in Ph2 obesity trial
Protein therapy, metabolic, GLP-1 receptor agonist, obesity, depot injection - Read more

Dyne Therapeutics' zeleciment rostudirsen sustains respiratory and cardiac benefits through 24 months in Ph1/2 Duchenne muscular dystrophy study
Antisense oligonucleotide, neurological, exon skipping, Duchenne muscular dystrophy, dystrophin - Read more

Kainova Therapeutics reports positive Ph1 results for DT-9081 EP4 receptor antagonist in advanced solid tumors
Small molecule, cancer, EP4 receptor antagonist, solid tumors, immunosuppression - Read more

Telix Pharmaceuticals' TLX591-Tx (lutetium-177 rosopatamab tetraxetan) meets Ph3 safety objectives for metastatic castration resistant prostate cancer
Antibody, cancer, radioconjugate, prostate cancer, PSMA target - Read more

Laekna reports positive Ph1 results for LAE102 monoclonal antibody targeting obesity in postmenopausal women
Antibody, metabolic, monoclonal antibody, obesity, cardiometabolic diseases, postmenopausal women - Read more

Breakout Ventures raises $114M third fund, supporting AI-focused early-stage biotechs
AI/ML platform, early-stage, venture capital, drug discovery - Read more

Calidi Biotherapeutics raises $6M public offering, developing targeted genetic medicines
Gene therapy, targeted genetic medicines, biotechnology, clinical-stage - Read more

MindImmune raises $5M investment, immune-focused therapies for neurodegenerative diseases
Neurological, Alzheimer disease, immune-focused therapies, preclinical - Read more

CSL breaks ground on $1.5B plasma medicine plant expansion in Illinois, creating 300 jobs by 2031
Plasma-derived therapy, immunodeficiency, operational, major transaction - Read more

Eli Lilly pledges $500M to South Korea biopharma industry with Gateway Labs incubator following Roche's similar investment
Strategic, major transaction, operational, investment - Read more

Cassava Sciences rebrands as Filana Therapeutics, pivoting to epilepsy after failed Alzheimer's program and legal settlements
Small molecule, neurological, strategic, operational - Read more

Cell and gene therapy manufacturing market projected to reach $146B by 2032, up from $19.3B in 2024
Cell and gene therapy, multiple therapeutic areas, strategic, major transaction, manufacturing expansion - Read more

Medtronic to acquire Scientia Vascular for $550M to expand stroke care treatment portfolio
Medical device, neurological, strategic, major transaction - Read more

FDA proposes streamlined biosimilar testing guidance potentially saving drugmakers $20M in development costs
Biosimilar, regulatory, cost reduction, operational - Read more

Capricor Therapeutics' deramiocel cell therapy gets August FDA review date for Duchenne muscular dystrophy cardiomyopathy
Cell therapy, neuromuscular disease, Duchenne muscular dystrophy, cardiomyopathy, deramiocel - Read more

FDA sets scope for pre-submission facility meetings to reduce manufacturing-related drug approval rejections
Regulatory, operational, strategic, manufacturing - Read more

Senator Ron Johnson launches investigation into FDA rare disease therapy rejections, targeting recent controversial denials
Gene therapy, neurological, regulatory, rare disease - Read more

Sandoz creates dedicated biosimilar unit led by new hire ahead of $650B patent cliff opportunity
Biosimilar, strategic, operational, financial - Read more

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f5 Therapeutics shuts down after six years amid brutal funding environment for early-stage biotech companies
Molecular glue, operational, financial, early-stage biotech - Read more

BioNTech stock drops 22% as founders Şahin and Türeci announce departure to start new company
mRNA, oncology, strategic, operational - Read more

Voyager Therapeutics pauses preclinical Alzheimer's APOE program 8 months after launch to prioritize advanced assets
Gene therapy, neurological, strategic, cost reduction - Read more

Novo Nordisk receives FDA warning letter over adverse event reporting failures at US headquarters
GLP-1 agonist, diabetes, regulatory, operational - Read more

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