U.S. Food and Drug Administration– tag –
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FDA Streamlines Nonclinical Studies for Biologics and Conjugated Products, Accepting NAMs for ADCs to Reduce Non-Human Primate Use
FDA USA Overview The FDA's Center for Drug Evaluation and Research (CDER) is streamlining nonclinical studies for biologics and conjugated products, including Antibody-Drug Conjugates (ADCs) and CD3 bispecific T-cell engagers. For ADCs w... -
FDA Approves Oral Peptide Icorokinra for Moderate-to-Severe Plaque Psoriasis, Driven by Advanced DDS
Dermatology Times USA Overview The FDA has approved icorokinra, the first oral IL-23 receptor antagonist peptide for moderate-to-severe plaque psoriasis, representing a significant breakthrough in oral peptide delivery systems (DDS). Thi... -
FDA Grants Breakthrough Therapy Designation to Merck’s Investigational KRAS G12C Inhibitor Calderasib (MK-1084) in Combination with KEYTRUDA for Metastatic NSCLC
BioSpace USA Overview Merck announced that its investigational oral KRAS G12C inhibitor, calderasib (MK-1084), in combination with KEYTRUDA® (pembrolizumab), received FDA Breakthrough Therapy Designation for newly diagnosed metastatic KR... -
Biogen’s Salanersen Receives FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy (SMA)
PMLiVE USA Overview Biogen's investigational antisense oligonucleotide (ASO), salanersen, has received FDA Breakthrough Therapy Designation for Spinal Muscular Atrophy (SMA). This designation is based on early clinical data showing impro... -
FDA Grants Fast Track Designation to Investigational Gene Therapy for Rare Inherited Eye Disease
FDA Press Release USA Overview The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to an investigational gene therapy for a serious rare inherited eye disease. This designation aims to facilitate development an... -
Eli Lilly’s MASH Triple Agonist Shows Promise in Phase 2 Interim Data, Suggesting Improvement in Liver Fibrosis and Inflammation
Eli Lilly Investor Relations / MedCentral USA Overview Eli Lilly announced promising interim data from its ongoing Phase 2 trial of a triple agonist therapeutic for Metabolic Dysfunction-Associated Steatohepatitis (MASH). The data sugges... -
Arvinas Secures IND Clearance for Oral LRRK2 Degrader ARV-102, Expanding Neurodegenerative Pipeline and Partnering with Michael J. Fox Foundation
Arvinas Press Release / MarketBeat / GLOBE NEWSWIRE USA Overview Arvinas announced FDA approval of its Investigational New Drug (IND) application for ARV-102, an oral PROTAC protein degrader designed for specific neurodegenerative diseas... -
US Department of Veterans Affairs Launches MDMA-Assisted Mental Health Therapy Trial
VA News (US Department of Veterans Affairs) USA Overview The U.S. Department of Veterans Affairs (VA) has initiated a clinical trial for MDMA-assisted mental health therapy, following the FDA's Breakthrough Therapy designation for MDMA, ... -
FDA Approves Hepcludex, First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
FDA (Press Release), European AIDS Treatment Group USA Overview The U.S. FDA has approved Hepcludex (bulevirtide-gmod) injection as the first treatment for chronic hepatitis delta virus (HDV) infection in adults, with or without compensa... -
Daiichi Sankyo Unveils Extensive Oncology Portfolio Progress at ASCO; Datopotamab Deruxtecan Approved for First-Line mTNBC
Daiichi Sankyo (Press Release), MedCity News, ADC Review, FirstWord Pharma Japan Overview Daiichi Sankyo will present over 25 abstracts at the 2026 ASCO Annual Meeting, showcasing its leading oncology portfolio, including new clinical da...
