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FDA approves Arcutis Biotherapeutics' ZORYVE (roflumilast) cream label expansion for plaque psoriasis in children aged 2+
Small molecule, autoimmune, plaque psoriasis, PDE4 inhibitor, pediatric patients, topical therapy - Read more

Boulevard Bio, Metis TechBio strike $1.6B deal for trispecific TCE MTS-128 targeting autoimmune diseases
Licensing deal, autoimmune, trispecific T-cell engager, AI/ML, milestone payments, royalties - Read more

UCL, Eisai renew 5-year neurodegenerative disease drug discovery partnership with £10M ($13.3M) invested
Research collaboration, neurological, antibody, drug discovery, neurodegenerative disease - Read more

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BeOne's Brukinsa (zanubrutinib) meets Ph3 goal, reducing progression risk by 43% in first-line mantle cell lymphoma
Small molecule, cancer, BTK inhibitor, mantle cell lymphoma, non-Hodgkin lymphoma, combination therapy - Read more

Skyhawk Therapeutics' (SKY-0515) Ph1/2 trial shows favorable 12-month results in Huntington's disease with mutant huntingtin reduction
Small molecule, neurological, RNA splicing modifier, Huntington's disease, mutant huntingtin, PMS1 - Read more

Genmab, AbbVie's Epkinly (epcoritamab) meets Ph3 progression-free survival goal in relapsed or refractory diffuse large B-cell lymphoma
Antibody, cancer, bispecific antibody, diffuse large B-cell lymphoma, CD3xCD20, combination therapy - Read more

Sanofi seeks US label expansion for Nexviazyme (avalglucosidase alfa) after Ph3 win in infantile-onset Pompe disease
Protein therapy, neurological, enzyme replacement therapy, Pompe disease, GAA enzyme deficiency - Read more

Beeline Medicines raises $126.3M Series A extension, advancing autoimmune programs from Bristol Myers Squibb
Autoimmune, small molecule, lupus, oral therapy, clinical-stage - Read more

smartbax closes €6.3M ($7.2M) Pre-Series A to advance lead antibiotic program to IND filing
Infectious disease, small molecule, antibiotics, preclinical, multi-drug resistant - Read more

Zelluna awarded NOK 16M ($1.6M) Research Council of Norway grant, supporting Phase 1 cancer study
Cell therapy, oncology, TCR-NK platform, allogeneic, clinical-stage - Read more

Tissium raises €60M ($68.6M) in Series D2 equity and debt, advancing biomorphic polymer tissue reconstruction
Biomaterials, tissue reconstruction, polymers, cardiovascular, commercial-stage - Read more

Nuvectis Pharma prices $100M public offering to advance oncology and complement-related therapy programs
Clinical-stage, oncology, autoimmune, small molecule - Read more

FDA selects Eli Lilly, Regeneron, Fujifilm, Kriya Therapeutics, others for PreCheck Pilot Program to boost U.S. drug manufacturing
Drug manufacturing, rare disease, operational, strategic - Read more

FDA veteran Richard Pazdur under consideration to rejoin agency in senior leadership role
Oncology, leadership, operational, strategic - Read more

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FDA rejects Unicycive Therapeutics' oxylanthanum carbonate (OLC) again over third-party manufacturing deficiencies for hyperphosphatemia in chronic kidney disease
Small molecule, metabolic, hyperphosphatemia, chronic kidney disease, manufacturing deficiency - Read more

Vistagen's (fasedienol) Ph3 trial fails in social anxiety disorder, company eyes single pivotal Ph3 path to FDA approval
Small molecule, neurological, intranasal drug, social anxiety disorder, pherine - Read more

NEJM retracts pivotal Amgen Tavneos study amid FDA data manipulation investigation
Small molecule, rare disease, regulatory, competitive - Read more

FDA delays Praxis Precision Medicine's epilepsy drug relutrigine decision by three months to December
Small molecule, epilepsy, regulatory, financial - Read more

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