Category Regulatory

Datopotamab Deruxtecan Improves Survival in Advanced Non-Squamous NSCLC: TROPION-Lung01 Phase III Results

High-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which previously met the primary endpoint of progression-free survival (PFS), numerically favored datopotamab deruxtecan (Dato-DXd) over docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)…

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UCB Announces Publication in The Lancet of Phase 3 Bimekizumab▼ Trials for Moderate to Severe Hidradenitis Suppurativa

UCB, a leading global biopharmaceutical company, has announced the publication of results from the Phase 3 BE HEARD I and BE HEARD II trials in The Lancet. These trials evaluated the effectiveness and safety of bimekizumab, an inhibitor of IL-17A…

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FDA Grants Breakthrough Status to Roche’s Inavolisib for Advanced HR+, HER2- Breast Cancer

Roche announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant. This treatment is for adult patients with PIK3CA-mutated, hormone receptor-positive, human…

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Brenmiller’s Project Pipeline Surges to 49 Projects, Encompassing Over $500 Million Potential Value in 12 Industries Across 13 Countries

The leading developer in thermal energy storage (“TES”) globally, Brenmiller, announced significant expansion in its project pipeline, marking a record level for the Company. As of May 1, 2024, Brenmiller boasts a project pipeline comprising 49 potential contracts at various…

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Omeros Corporation Reports First Quarter 2024 Financial Results

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders such as complement-mediated diseases, cancers, and addictive and compulsive disorders, has reported…

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