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Tissue Dynamics and Galmed Pharmaceuticals partner to develop a human-centered cardiac fibrosis platform that will focus on chronic post-MI remodeling and HFpEF, linking lipid metabolism, SCD1 activity, fibrosis, and impaired tissue repair.
USFDA | 07/05/2026 | By News Bureau
US FDA Proposes Excluding Semaglutide, Tirzepatide and Liraglutide from 503B Bulks List
The US Food and Drug Administration (FDA) proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, citing no clinical need for compounding these GLP-1 drugs by outsourcing facilities.
USFDA | 04/05/2026 | By News Bureau
US FDA Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer
US Food and Drug Administration (FDA) advisory panel backs TRUQAP (capivasertib) with abiraterone and ADT for PTEN-deficient metastatic hormone-sensitive prostate cancer, based on positive phase 3 CAPItello-281 results showing favorable benefit-risk.
USFDA | 01/05/2026 | By News Bureau
Orca Bio Receives US FDA RMAT Designation for Orca-Q in Blood Cancers
Orca Bio receives US Food and Drug Administration (FDA) RMAT designation for Orca-Q in high-risk hematologic malignancies, backed by promising phase 1 data on survival and GVHD outcomes, with further results expected in 2026.
USFDA | 30/04/2026 | By News Bureau
AbbVie Submits FDA Application for SKYRIZI Subcutaneous Induction in Crohn's Disease
AbbVie Inc. submits an application to the US Food and Drug Administration (FDA) for SKYRIZI (risankizumab-rzaa) subcutaneous induction in Crohn’s disease, supported by Phase 3 AFFIRM data, offering a potential new treatment option.
USFDA | 29/04/2026 | By News Bureau
Soligenix Reports Phase 3 FLASH2 Interim Results for HyBryte in Cutaneous T-Cell Lymphoma
Soligenix reports Phase 3 FLASH2 interim results for HyBryte in Cutaneous T-Cell Lymphoma, with the study recommended for early termination due to futility.
USFDA | 29/04/2026 | By News Bureau
US FDA Approves CAPLYTA (lumateperone) sNDA for Schizophrenia Relapse Reduction
US Food and Drug Administration (FDA) approves CAPLYTA (lumateperone) sNDA for schizophrenia, showing a 63 percent reduction in relapse risk and 84 percent relapse-free patients over six months, with strong long-term safety and stability data.
USFDA | 28/04/2026 | By News Bureau
Cellenkos Inc. Wins US FDA Clearance for Phase 2 Trial of CK0801 in Aplastic Anemia
Cellenkos Inc. receives US Food and Drug Administration (FDA) clearance to initiate a Phase 2 multicentre trial of CK0801, evaluating safety and efficacy of cord blood-derived Tregs in transfusion-dependent aplastic anemia patients.
USFDA | 27/04/2026 | By News Bureau
US FDA Approves Regeneron's Otarmeni, First Gene Therapy for Genetic Hearing Loss
US Food and Drug Administration (FDA) approves Regeneron’s Otarmeni, the first AAV-based gene therapy, offering a potential treatment for severe-to-profound hearing loss.
USFDA | 27/04/2026 | By News Bureau
Morepen Laboratories Bags Zero-Observation USFDA Inspection for Fourth Time
Morepen Laboratories clears its fourth consecutive USFDA inspection at the Masulkhana facility with zero observations (NIL 483), reinforcing its CDMO strength following a INR 825 crore global manufacturing mandate.
USFDA | 21/04/2026 | By News Bureau
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