U.S. Food and Drug Administration– tag –
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Prelude Therapeutics Receives IND Clearance for Oral KAT6A Degrader PRT13722 in HR+/HER2- Breast Cancer Phase 1 Study
MarketBeat USA Overview On September 10, 2026, Prelude Therapeutics announced FDA Investigational New Drug (IND) clearance for PRT13722, an oral KAT6A selective degrader. This compound is being developed for HR-positive/HER2-negative bre... -
FDA Approves Multiple Novel Cancer Therapeutics, Including Multi-Selective RAS(ON) Inhibitor Daraxonrasib and Next-Gen ADCs for Difficult-to-Treat Cancers
The ASCO Post USA Overview The U.S. FDA announced several groundbreaking cancer drug approvals on September 10, 2026, including daraxonrasib, a multi-selective RAS(ON) inhibitor, for metastatic pancreatic adenocarcinoma. Other approvals ... -
Rani Therapeutics Achieves 84% Bioavailability for Oral Ustekinumab Biosimilar; Oral GLP-1s Drive Commercial Success in Biopharma Delivery
Drug Delivery Leader USA Overview The successful FDA approval and commercial launch of oral semaglutide (Wegovy) and orforglipron highlight the critical role of oral delivery in chronic disease management, significantly improving patient... -
OS Therapies Strengthens FDA & MHRA Alignment, Joins Project Orbis for OST-HER2 Metastatic Osteosarcoma Program
OS Therapies USA Overview OS Therapies announced strengthened alignment with the FDA and MHRA and approval to join Project Orbis for its lead candidate, OST-HER2 (a next-generation tunable ADC) program for metastatic osteosarcoma. Projec... -
Nutshell Therapeutics’ NRF2 Molecular Glue Degrader NTS231 Clears FDA IND, Becomes China’s First and World’s Second to Enter Clinical Development
Insight, China's Pharmaceutical Industry China Overview Nutshell Therapeutics' NRF2 molecular glue degrader, NTS231, has cleared FDA IND, becoming the first from China and second globally to enter clinical development as a novel therapeu... -
FDA Approves Vertex’s Zanvastro: First Disease-Modifying ASO Therapy for Alexander Disease
Healio USA Overview The U.S. FDA has approved Zanvastro (zilgannersen), an antisense oligonucleotide (ASO) therapy from Vertex Pharmaceuticals, for pediatric and adult patients with Alexander disease. This marks the first disease-modifyi... -
Eli Lilly’s Foundayo® (Orforglipron) Receives FDA Approval as First Oral Non-Peptide GLP-1 Receptor Agonist, Demonstrates Significant Weight Loss and Cardiometabolic Improvement
Obesity Medicine Review Unknown Overview Eli Lilly's Orforglipron, branded as Foundayo®, has received FDA approval as the latest oral GLP-1 receptor agonist. Distinguishing itself from oral semaglutide (Wegovy®) as a small-molecule, non-... -
BioNTech Announces gotistobart Phase III Achieves Median OS of 18.5 Months in Squamous NSCLC at WCLC 2026
european biotechnology Germany Overview At the World Conference on Lung Cancer (WCLC) 2026 in Seoul, BioNTech presented pivotal data from the Phase III PRESERVE-003 trial for gotistobart (BNT316/ONC-392), a pH-sensitive anti-CTLA-4 antib... -
Ionis’ Zanvastro (Zilganersen) Gains FDA Approval as First Disease-Modifying ASO Therapy for Alexander Disease
Fierce Pharma USA Overview Ionis Pharmaceuticals has received FDA approval for Zanvastro (zilganersen), an antisense oligonucleotide (ASO) therapy, as the first disease-modifying treatment for Alexander disease. Zanvastro operates by spe... -
Moderna’s RSV Vaccine mRESVIA® Receives FDA Approval as mRNA Therapeutics Advance in Non-Vaccine Applications
Facebook (Vaxcyte, Vivaldi Biosciences) USA Overview Moderna's RSV vaccine mRESVIA® gained FDA approval following Breakthrough Therapy Designation, reaffirming the power of mRNA technology in infectious disease prevention. Concurrently, ...
