The Scientist3h
IND Applications Are Tedious. Can AI Help?
Drug developers can now leverage large language models to draft regulatory documents, which they hope will shorten the time ...
Targeted Oncology23h
FDA Clears IND Application for EVM14 Across Cancers
The FDA cleared the investigational new drug (IND) application for EVM14. EVM14 is an off-the-shelf tumor-associated antigen ...
Verve Therapeutics announces FDA clearance of IND application for VERVE-102
Verve Therapeutics (VERV) announced the clearance of its Investigational New Drug application by the U.S. Food and Drug Administration for ...
Palatin Technologies, Inc.: Palatin's Oral MC4R Agonist PL7737 Receives FDA Orphan Drug Designation for Obesity Due to Leptin Receptor Deficiency
Initiated IND-enabling toxicology program IND submission planned for 4Q25; Clinical data expected in 1H26 CRANBURY, N.J., March 25, 2025 /PRNewswire/ -- Palatin ...
Contract Pharma1d
Everest Medicine’s IND Application for EVM14 Cleared by FDA
The FDA has cleared Everest Medicines’ Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) ...
SineuGene Therapeutics Announces FDA IND Clearance for SNUG01, a First-in-Class TRIM72-Targeted Gene Therapy for ALS
SineuGene Therapeutics Co., Ltd. ("SineuGene"), a clinical-stage biotech company pioneering innovative therapies for neurological disorders, today announced that the U.S. Food and Drug Administration ...