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News about "US FDA Approval"
FDA Grants Breakthrough Therapy Designation to Sanofi's Wayrilz for Rare Blood Disorder wAIHA
The US FDA has granted breakthrough therapy designation to Wayrilz (rilzabrutinib) for warm autoimmune haemolytic anaemia, while Japan’s health ministry awarded orphan status, accelerating development for the rare disorder.
US FDA Approval | 11/02/2026 | By News Bureau
FDA Accepts IND for Affinia's AFTX-201 Gene Therapy in BAG3 Dilated Cardiomyopathy
Affinia Therapeutics receives FDA clearance to begin clinical testing of AFTX-201, a next-generation AAV gene therapy for BAG3-associated dilated cardiomyopathy, with Phase 1/2 UPBEAT trial set to begin in 2026.
US FDA Approval | 09/02/2026 | By News Bureau
FDA Grants Orphan Drug Designation to Zenocutuzumab for Rare Cholangiocarcinoma Subset
Partner Therapeutics secures Orphan Drug Designation for zenocutuzumab-zbco in NRG1 fusion-positive cholangiocarcinoma, strengthening development of targeted therapy for this aggressive rare cancer.
US FDA Approval | 09/02/2026 | By News Bureau
Hologic's Aptima HPV Assay Receives US FDA Approval for Primary Cervical Cancer Screening
US FDA approves Hologic’s mRNA-based Aptima HPV assay for clinician-collected primary screening, expanding cervical cancer testing options and enhancing early detection of high-risk infections.
US FDA Approval | 07/02/2026 | By News Bureau
Lupin Launches Topiramate Extended-Release Capsules in US Following FDA Approval
Lupin rolls out FDA-approved generic topiramate extended-release capsules in the US for epilepsy and migraine treatment.
US FDA Approval | 05/02/2026 | By News Bureau
Nanox Secures US FDA Clearance for TAP2D Image Enhancement Software for ARC Systems
FDA grants 510(k) clearance to Nanox’s cloud-enabled TAP2D software, enabling 2D image generation from a single tomosynthesis scan and advancing its strategy to position ARC systems as primary diagnostic solutions.
US FDA Approval | 05/02/2026 | By News Bureau | 116
The FDA has granted Priority Review to Datroway for first-line treatment of metastatic triple-negative breast cancer patients ineligible for immunotherapy, with a regulatory decision expected in Q2 2026.
US FDA Approval | 04/02/2026 | By News Bureau
Trace Biosciences Secures FDA IND Clearance for First Nerve-Specific Fluorescent Imaging Agent
FDA clears IND application for LGW16-03, enabling Trace Biosciences to begin first-in-human trials of its nerve-targeted imaging agent designed to reduce accidental nerve injuries during surgery.
US FDA Approval | 02/02/2026 | By News Bureau | 100
FDA Grants Breakthrough Therapy Designation to Biogen's Litifilimab for Cutaneous Lupus
Biogen’s investigational monoclonal antibody litifilimab receives FDA Breakthrough Therapy designation, marking a major step toward targeted treatment for cutaneous lupus erythematosus.
US FDA Approval | 29/01/2026 | By News Bureau
Innovent Biologics’ tri-specific antibody IBI3003 has received FDA Fast Track Designation for heavily pretreated relapsed or refractory multiple myeloma, supported by promising early clinical efficacy and safety data.
US FDA Approval | 27/01/2026 | By News Bureau | 110
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