Pharm Exec1d
Johnson & Johnson Initiates New Drug Application for TAR-200 in BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer
The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study, which demonstrated an 83.5% ...
New Atlas6h
Got milk? Startup develops milk-based targeted drug-delivery technology
A couple of University of Nebraska professors have launched a startup company with the goal of bringing to market an ...
Healio2d
FDA clears investigational new drug application for lorundrostat in OSA, hypertension
The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...
News Medical on MSN3h
Researchers launch startup to revolutionize targeted drug delivery using milk exosomes
Two Nebraska researchers have launched a startup company aimed at bringing to market an innovative method for delivering therapeutics, gene editing tools, plasmids and more to targeted locations in ...
Cure Today13d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...
Targeted Oncology1d
FDA Clears 225Ac-SSO110 for Phase 1/2 SCLC and Merkel Cell Carcinoma Trial
The FDA has approved the investigational new drug application of 225Ac-SSO110, allowing for the start of a phase 1/2 trial in ...
FDA Unveils Grounds For Rejecting Vanda Pharmaceuticals Stomach Paralysis Candidate
FDA denies Vanda's Tradipitant application for gastroparesis, urging new trials for efficacy and safety. Vanda disputes the ...
Targeted Oncology9d
FDA Clears Investigational New Drug Application for REC-4539 in SCLC
The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...
Business Insider3d
Hutchmed announces NMPA approval for Orpathys supplemental new drug application
Hutchmed (HCM) announces that the supplemental new drug application for Orpathys has been granted approval by the China National Medical Products Administration, or NMPA, for the treatment of adult ...
Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
JD Supra9d
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...