U.S. Food and Drug Administration– tag –
-
Targeted Protein Degradation (TPD) Enters Decisive Clinical Phase, Evolving Beyond PROTACs to Multifunctional Therapeutics
European Biotechnology Magazine Europe Overview Targeted protein degradation (TPD) is poised for a major clinical breakthrough, with 2026 marking a decisive phase as a diverse pipeline of next-generation degraders, including molecular gl... -
Denali Therapeutics Announces Breakthroughs in Blood-Brain Barrier Biologic Delivery: AVLAYAH™ Receives FDA Accelerated Approval for Hunter Syndrome
Denali Therapeutics USA Overview Denali Therapeutics CEO Dr. Ryan Watts will deliver a plenary address at AAIC 2026, highlighting the company's breakthrough advancements in delivering biologic therapies across the blood-brain barrier (BB... -
FDA Grants Traditional Approval to Retevmo (selpercatinib) for Locally Advanced or Metastatic RET Fusion-Positive Solid Tumors, Expanding Patient Access
FDA USA Overview On July 14, 2026, the FDA granted traditional approval to Eli Lilly and Company's Retevmo (selpercatinib) for patients aged two years and older with locally advanced or metastatic RET fusion-positive solid tumors that ha... -
Pfizer and Arvinas’ Veppanu (vepdegestrant) Gains FDA Approval, Revolutionizing ESR1-Mutated Advanced Breast Cancer as First PROTAC
DCAT Value Chain Insights USA Overview In 2026, Pfizer and Arvinas' Veppanu (vepdegestrant) received FDA approval for advanced breast cancer with ESR1 mutations, becoming the first FDA-approved PROTAC. This drug offers a groundbreaking o... -
FDA Approves Celcuity’s Revtorpyk (gedatolisib) for HR-Positive, HER2-Negative Metastatic Breast Cancer in New Combination Regimen
FDA USA Overview On July 14, 2026, the FDA approved Celcuity Inc.'s Revtorpyk (gedatolisib) for adult patients with HR-positive/HER2-negative metastatic breast cancer without PIK3CA mutation. The drug is approved for use in combination w... -
Eli Lilly’s Foundayo (orforglipron) Receives FDA Approval, Ushering in a New Era of Oral GLP-1 RAs for Obesity Treatment
2 Minute Medicine USA Overview On April 1, 2026, Eli Lilly's Foundayo (orforglipron) gained FDA approval for obesity treatment, marking the first non-peptide oral GLP-1 receptor agonist without food or water timing restrictions. This bre... -
PharmTech Analyzes Mid-2026 Key Trends: AI Integration in Drug Discovery and Manufacturing, Strengthened Supply Chains, and New Drug Approvals
PharmTech USA Overview PharmTech released its 'Midyear 2026 Check-in' report, analyzing key pharmaceutical industry trends: AI integration in drug discovery and manufacturing, reinforced supply chain resilience, and new drug approval dyn... -
The Critical Need for Human-Relevant Models in Drug Discovery to Accelerate Development with AI and Organoids
Technology Networks UK Overview This article discusses advancements in New Approach Methodologies (NAMs) in drug discovery, emphasizing their potential beyond the laboratory. It highlights the necessity for new training approaches and st... -
From Silicon to Synapse: AI Giants Target Pharma, Yet Clinical Timelines Threaten Capital Returns
36Kr China Overview Major AI players, including Anthropic, OpenAI, and Google's Isomorphic Labs, are rapidly entering the life sciences, leveraging AI to accelerate early drug discovery. However, the inherently long timelines for clinica... -
NIH’s NCATS Secures FDA IND Clearance for Gene Therapy Targeting Ultra-Rare Multiple Sulfatase Deficiency
National Center for Advancing Translational Sciences - NIH USA Overview The National Center for Advancing Translational Sciences (NCATS), part of the NIH, announced FDA clearance of an Investigational New Drug (IND) application for a gen...
