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The Good News

THE GOOD
Approvals & Labels

Partner Therapeutics' Bizengri (zenocutuzumab-zbco) gains FDA label expansion for NRG1 fusion-positive cholangiocarcinoma based on Ph1/Ph2 data
Antibody, cancer, bispecific antibody, cholangiocarcinoma, NRG1 fusion, HER2/HER3 target - Read more

argenx's VYVGART (efgartigimod alfa-fcab) receives FDA label expansion for all adult generalized myasthenia gravis serotypes
Protein therapy, autoimmune, monoclonal antibody, generalized myasthenia gravis, FcRn antagonist, efgartigimod - Read more

Genentech's Ocrevus (ocrelizumab) receives FDA approval for pediatric relapsing-remitting multiple sclerosis in patients aged 10 and older
Antibody, autoimmune, monoclonal antibody, multiple sclerosis, pediatric patients, CD20 target - Read more

Knight Therapeutics' TAVALISSE (fostamatinib) receives Brazil ANVISA approval for chronic immune thrombocytopenia in adults
Small molecule, autoimmune, SYK inhibitor, immune thrombocytopenia - Read more

NICE recommends Johnson & Johnson's RYBREVANT plus chemotherapy for EGFR exon 20 NSCLC via Cancer Drugs Fund
Monoclonal antibody, oncology, regulatory, managed access - Read more

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More Good News

THE GOOD
Business Development & Partnerships

LenioBio, Twist Bioscience partner to accelerate AI-designed protein wet-lab validation using ALiCE platform
Research collaboration, AI/ML, drug discovery, antibody, cell-free expression - Read more

THE GOOD
Clinical Trials

Raynovent Biotech's ZSP1601 meets primary endpoint in Ph2b trial for metabolic dysfunction-associated steatohepatitis
Small molecule, metabolic, pan-PDE inhibitor, MASH, liver fibrosis - Read more

THE GOOD
Earnings & Finances

Gilead raises Yeztugo 2026 sales target to $1B after strong launch trajectory
Small molecule, infectious disease, revenue impact, CAR-T, oncology - Read more

Gilead raises 2026 sales outlook after strong HIV growth, despite expected earnings hit from $11.5B acquisition spending
Cell therapy, oncology, major transaction, financial, strategic - Read more

THE GOOD
Fundraises

Artiva Biotherapeutics prices $300M offering of common stock and pre-funded warrants, autoimmune cell therapies
Cell therapy, autoimmune, clinical-stage - Read more

THE GOOD
IPOs

Quantinuum plans IPO to fund quantum computing platform for drug discovery
Quantum computing, AI/ML platform, drug discovery, platform technology - Read more

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The Bad News

THE BAD
Earnings & Finances

Daiichi Sankyo takes $610M profit hit from ADC manufacturing overcapacity amid shifting demand forecasts
Antibody-drug conjugate, oncology, operational, financial, cost reduction - Read more

THE BAD
Lawsuits

Capricor Therapeutics sues US partner NS Pharma for breach of contract over deramiocel launch failures
Cell therapy, rare disease, operational, financial - Read more

THE BAD
Regulatory

Biogen, Eisai face 3-month FDA delay for subcutaneous Leqembi (lecanemab) initiation in Alzheimer's disease
Antibody, neurological, monoclonal antibody, Alzheimer's disease, amyloid, subcutaneous delivery - Read more

👹 The Ugly News 👹

THE UGLY
Politics & Policy

Trump expected to remove FDA Commissioner Marty Makary amid leadership turmoil, reports say
Leadership change, regulatory, operational, strategic - Read more

You’re all caught up on the latest Pharma & Biotech News!

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