Category Regulatory

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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GlycoMimetics Reveals Findings from Crucial Phase 3 Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia (AML)

GlycoMimetics, Inc. (Nasdaq: GLYC), a biotechnology company specializing in advanced therapies for cancer and inflammatory conditions, has released the top-line results from its Phase 3 global pivotal trial of uproleselan involving 388 patients with relapsed/refractory (R/R) acute myeloid leukemia (AML).…

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