Targeted Oncology1d
FDA Clears Investigational New Drug Application for CD-001 in Oncology
Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.
FDA rejects Vanda Pharmaceuticals' application to bring key drug to market
A D.C. drugmaker has been dealt a major setback in its long-running bid to bring its treatment for a chronic gastrointestinal ...
Cure Today13d
FDA OKed New Drug Application for Novel Glioblastoma Treatment
The Food and Drug Administration (FDA) has cleared an investigational new drug application for the novel treatment, APTN-101, ...
Arrowhead Pharmaceuticals Stock Climbs on Plans To Seek FDA Approval for New Drug
Key Takeaways Arrowhead Pharmaceuticals reported a Phase-3 study of its medicine for a rare genetic disorder met all its ...
ndtvprofit17d
Shilpa Medicare And Unicycive Submit New Drug Application To U.S. FDA
Shares of Shilpa Medicare closed 6.03% higher at Rs 810.60 apiece, compared to a 0.25% rise in the benchmark BSE Sensex.
FierceBiotech3d
FDA scraps adcomm for Applied's rare disease drug ahead of November decision
After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...
Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Metabolic Disorder Drug
Applied Therapeutics stock rises as the FDA no longer requires an Advisory Committee meeting, keeping the Priority Review on ...
Zevra Therapeutics' Drug Becomes First FDA-Approved Treatment For Ultra-Rare Neurodegenerative Disease
The FDA has approved Zevra Therapeutics' Miplyffa (arimoclomol) as the first treatment for neurological symptoms of ...
Vanda Pharmaceuticals decries FDA’s rejection of stomach paralysis drug as unjust
Vanda pharmeucitals received a rejection for its drug tradipitant, causing the company management to criticize the FDA.
Milwaukee Journal Sentinel21h
Another AZ county joins federal program to combat drug trafficking
Nine counties were included prior to Thursday's announcement that Yavapai County's application to join had been ... Office of ...
Arrowhead Pharmaceuticals Shares Climb on Plans to File New Drug Application for Plozasiran
Shares of Arrowhead Pharmaceuticals on Tuesday climbed in pre-market trading after the company said that it plans to file a new drug application with the U.S. Food and Drug Administration by the end ...
Business Wire7d
Positive Pooled Data from Nuvation Bio’s TRUST-I and TRUST-II Studies Highlight Taletrectinib’s Best-in-Class Potential for Patients with Advanced ROS1-positive NSCLC ...
Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today a ...