Category Regulatory

Sarclisa Receives FDA Priority Review for Treating Newly Diagnosed Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Sarclisa (isatuximab) for Priority Review. The application is for the investigational use of Sarclisa combined with bortezomib, lenalidomide, and dexamethasone (VRd) to treat transplant-ineligible…

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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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