Today, Astellas announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Biologics License Application (BLA) for zolbetuximab, a groundbreaking investigational monoclonal antibody targeting claudin (CLDN) 18.2. This resubmission is intended for the first-line treatment…
Today, Pfizer released extended findings from the Phase 3 CROWN trial, examining the efficacy of LORBRENA® (lorlatinib), a third-generation ALK inhibitor, versus XALKORI® (crizotinib) in previously untreated patients with ALK-positive advanced non-small cell lung cancer (NSCLC). Following a median follow-up…
The U.S. Food and Drug Administration (FDA) has approved Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone at least two prior…
Be Biopharma Announces FDA Clearance for BE-101 IND Application in Hemophilia B Be Biopharma, Inc. (“Be Bio”), a pioneer in Engineered B Cell Medicines (BCMs), has announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug…
A clinical-stage biotechnology company developing biologics to enhance regulatory T cell (Treg) function, Coya Therapeutics, has announced that MSCI has included its shares in the MSCI USA Micro Cap Index as of the market close on May 31, 2024. The…
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…
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)…
Today, it was announced that new subgroup analyses from Ionis and AstraZeneca’s Phase 3 NEURO-TTRansform study of WAINUA™ (eplontersen) will be presented at the 2024 International Symposium on Amyloidosis (ISA) in Rochester, Minnesota, taking place from May 26 to May…
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…
Today, AstraZeneca unveiled its ambitious target to achieve $80 billion in Total Revenue by 2030, a significant increase from the $45.8 billion reported in 2023. This expansion will be fueled by substantial growth in its existing oncology, biopharmaceuticals, and rare…
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…
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…
