U.S. Food and Drug Administration– tag –
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Market Trends
Key FDA Approvals Anticipated for GLP-1 Pipeline in May 2026 Update
Prime Therapeutics - Portal USA Overview Four significant FDA approval decisions for GLP-1 related medications are expected in 2026, marking critical advancements in metabolic disease management. Eli Lilly's injectable Mounjaro is antici... -
Drug Discovery & DDS
Eli Lilly Seals Landmark $2.75 Billion AI Drug Discovery Alliance with Insilico Medicine
IntuitionLabs, TipRanks, Tech Funding News USA Overview Pharmaceutical giant Eli Lilly has forged a strategic drug discovery and development collaboration with AI biotech pioneer Insilico Medicine, valued at up to $2.75 billion. The deal... -
New Technology
Beyond GLP-1: Next-Gen Obesity Drug Race Accelerates with Multi-Agonist Therapies
The Elec Inc. South Korea Overview The race for next-generation obesity drugs is expanding beyond GLP-1 injections into multi-agonist therapies targeting multiple hormones. Eli Lilly's Retatrutide, a triple agonist for GLP-1, GIP, and gl... -
Drug Discovery & DDS
NEOK002: Next-Generation Bispecific ADC Targeting EGFR and MUC1 Enters Clinical Development for Solid Tumors
Conference Coverage AACR USA Overview NEOK002 (formerly ABL209), a bispecific antibody-drug conjugate (ADC), has entered clinical development, designed to concurrently target two key cancer antigens, EGFR and MUC1, implicated in epitheli... -
New Technology
BeOne Medicines’ BEQALZI™ (Sonrotoclax) Gains US FDA Approval for Relapsed/Refractory Mantle Cell Lymphoma as First BCL2 Inhibitor
Stock Titan USA Overview BeOne Medicines announced that BEQALZI™ (sonrotoclax) has received U.S. FDA approval for the treatment of relapsed/refractory Mantle Cell Lymphoma (MCL), marking it as the first BCL2 inhibitor for this indication... -
New Technology
GSK’s Bepirovirsen for Chronic Hepatitis B Receives FDA Priority Review and Breakthrough Therapy Designation
GSK USA Overview GSK announced that its investigational antisense oligonucleotide (ASO), Bepirovirsen, a candidate for chronic Hepatitis B, has been granted both Priority Review and Breakthrough Therapy Designation (BTD) by the U.S. FDA.... -
New Technology
FDA Grants Breakthrough Therapy Designation to Chronic Low Back Pain Treatment, Signaling Potential Shift for Cannabinoid-Derived Therapies
YouTube (CB1 Capital) USA Overview The U.S. FDA has granted Breakthrough Therapy Designation (BTD) for a treatment for chronic low back pain. This announcement potentially signals an emerging wave of designations for cannabinoid-derived ... -
Drug Discovery & DDS
Curanex Pharmaceuticals Reports Q1 2026 Progress, Phyto-N Advances Towards FDA IND Submission for Ulcerative Colitis and Pipeline Expands to Cancer Cachexia
Taiwan News Taiwan Overview US-based Curanex Pharmaceuticals provided a Q1 2026 update, focusing on its lead drug candidate, Phyto-N. The company is advancing Phyto-N towards a planned Investigational New Drug (IND) submission to the U.S... -
Market Trends
Eli Lilly’s Oral Orforglipron Effective in Older Adults with Obesity, Receives FDA Approval as Non-Peptide GLP-1 Offering Dosing Flexibility
Medscape USA Overview Eli Lilly's once-daily oral GLP-1 receptor agonist, orforglipron (Foundayo), demonstrated clinically significant weight loss and a favorable safety profile in obese adults aged 65 and older, similar to younger popul... -
Drug Discovery & DDS
siRNA Therapeutics: Advancements in Chemical Modification and Targeted Delivery Expand Clinical Horizons Beyond the Liver
MDPI Global Overview siRNA therapeutics are achieving significant clinical success driven by sophisticated chemical modifications and robust delivery systems. GalNAc conjugates have become the gold standard for liver-targeted therapies, ...