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FDA approves AstraZeneca and Daiichi Sankyo's Enhertu (fam-trastuzumab deruxtecan-nxki) for first-line HER2-positive metastatic breast cancer
Antibody-drug conjugate, cancer, breast cancer, HER2-positive, combination therapy, first-line treatment - Read more

LIB Therapeutics wins FDA approval for Lerochol (lerodalcibep-liga) PCSK9 inhibitor targeting hypercholesterolemia
Protein therapy, cardiovascular, PCSK9 inhibitor, hypercholesterolemia, LDL cholesterol - Read more

Sanofi in-licenses Adel Therapeutics Alzheimer's antibody ADEL-Y01, $80M upfront, $1.04B total deal value
Licensing deal, neurological, antibody, milestone payments - Read more

Adaptive Biotechnologies, Pfizer partner on TCR platform for rheumatoid arthritis, up to $890M milestones
Research collaboration, autoimmune, AI/ML, licensing deal, milestone payments - Read more

eXmoor Pharma, UCL establish strategic collaboration to accelerate cell and gene therapy development
Research collaboration, cell therapy, gene therapy, manufacturing, R&D - Read more

Sanofi, Dren Bio partner on autoimmune therapies, $100M upfront, $1.7B milestones
Research collaboration, autoimmune, antibody, milestone payments - Read more

Mochida Pharmaceutical, Duchesnay Inc. partner on Bonjesta license for pregnancy nausea treatment in Japan
Licensing deal, women's health, small molecule, regulatory approval - Read more

HK inno.N acquires Japanese rights for K-CAB from RaQualia Pharma, becomes 15.95% shareholder
Licensing deal, gastrointestinal, equity investment, joint research - Read more

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Kyverna Therapeutics' miv-cel CAR-T therapy meets Ph2 endpoints for stiff person syndrome, seeks first autoimmune approval
Cell therapy, autoimmune, CAR-T, stiff person syndrome, miv-cel - Read more

Immunome's varegacestat (gamma secretase inhibitor) heads to FDA after Ph3 success in desmoid tumors
Small molecule, cancer, gamma secretase inhibitor, desmoid tumors, rare disease, oral therapy - Read more

Orca Bio's Orca-T shows Ph3 survival improvement in hematological malignancies versus conventional stem cell transplant
Cell therapy, cancer, allogeneic T-cell immunotherapy, hematological malignancies, graft versus host disease, acute myeloid leukemia - Read more

Gilead's bictegravir/lenacapavir combo meets Ph3 endpoints for human immunodeficiency virus treatment switch study
Small molecule, infectious disease, HIV, combination therapy, antiretroviral - Read more

Greenwich LifeSciences reports 80% recurrence reduction with GLSI-100 immunotherapy in Ph3 breast cancer prevention trial
Vaccine, cancer, immunotherapy, breast cancer, HLA-A*02 - Read more

Radiopharm Theranostics' RAD 101 achieves 92% primary endpoint success in Ph2b brain metastases imaging trial
Small molecule, cancer, radiopharmaceutical, brain metastases, FASN target, PET imaging - Read more

Palvella Therapeutics reports positive Ph2 results for QTORIN (rapamycin) gel treating cutaneous venous malformations
Small molecule, rare disease, topical therapy, cutaneous venous malformations, rapamycin, pediatric - Read more

InnoCare Pharma's orelabrutinib (BTK inhibitor) meets Ph2b primary endpoint in systemic lupus erythematosus, gets Ph3 approval
Small molecule, autoimmune, BTK inhibitor, systemic lupus erythematosus - Read more

Chai Discovery raises $130M Series B, AI-powered drug design suite development
AI/ML platform, drug discovery, antibody, platform technology - Read more

Link Cell Therapies raises $60M Series A, developing next-gen CAR-T therapies
Cell therapy, CAR-T, oncology, solid tumors, logic-gating technology, preclinical - Read more

UC Irvine receives $12M grant for Huntington's stem cell therapy trial
Neurological, stem cell therapy, Huntington's disease, clinical-stage - Read more

Enveric Biosciences raises $3.1M warrant exercise, neuroplastogenic small molecules for psychiatric disorders
Neurological, small molecule, psychiatric disorders, preclinical - Read more

Pilatus Biosciences raises $14M pre-Series A for anti-CD36 mAb development
Oncology, antibody, immunotherapy, clinical-stage - Read more

Attivare Therapeutics receives $6.6M Gates Foundation grant for malaria vaccine development
Infectious disease, platform technology, vaccine development, immunomodulatory - Read more

Alphyn Biologics raises $25M Series B, clinical-stage dermatology therapeutics development
Clinical-stage, dermatology, atopic dermatitis, platform technology - Read more

Novo's oral semaglutide leads primary care physicians' preferences among developing oral obesity medications
GLP-1 receptor agonist, obesity, competitive, strategic - Read more

XOMA Royalty acquires Generation Bio for $4.29 per share plus contingent value rights
Gene therapy, strategic, major transaction, financial - Read more

Novo Nordisk launches Ozempic in India, pricing lowest dose at $24 weekly for diabetes market
Small molecule, diabetes, strategic, operational - Read more

FDA proactively awards Johnson & Johnson priority review voucher for Tecvayli-Darzalex multiple myeloma combination
Monoclonal antibody, oncology, regulatory, strategic - Read more

FDA removes barrier requiring individual patient data for real-world evidence in drug/device reviews
Regulatory, operational, strategic - Read more

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Aviceda Therapeutics' AVD-104 fails to outperform Izervay in Ph2 trial for geographic atrophy treatment
Nanoparticle therapy, ophthalmology, geographic atrophy, age-related macular degeneration, immune modulation - Read more

Sanofi's tolebrutinib (BTK inhibitor) fails Ph3 trial in primary progressive multiple sclerosis, FDA delays approval decision
Small molecule, neurological, BTK inhibitor, multiple sclerosis, liver toxicity - Read more

Argenx's Vyvgart (efgartigimod) fails Ph3 thyroid eye disease trial targeting FcRn receptor pathway
Protein therapy, autoimmune, FcRn inhibitor, thyroid eye disease, myasthenia gravis - Read more

Areteia Therapeutics terminates dexpramipexole Ph3 trials for eosinophilic asthma, winds down operations despite meeting primary endpoint
Small molecule, respiratory, eosinophilic asthma, dexpramipexole - Read more [Paywall]

FDA's Prasad overstated pediatric COVID vaccine deaths; scientists find zero-to-seven cases, not ten
mRNA vaccine, infectious disease, regulatory, operational - Read more

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