JD Supra37m
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
Pharm Exec2d
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% ...
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 MSN4h
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 ...
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 ...
New drug development tool could revolutionize industry
A University of Oklahoma professor and his team have discovered a new way to put atoms into drug molecules that could revolutionize the drug industry. The safer, cheaper, more environmentally friendly ...
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 ...
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.
MM&M23h
Rx Rundown: Johnson & Johnson, Eli Lilly, the FDA and more
N-Power Medicine, backed by Merck GHI, announced the acquisition of Syapse Holdings. Samsung Biologics and LigaChem extended their ADC services deal. Publicis Worldwide merged with Leo Burnett to form ...
ophthalmologytimes6d
FDA accepts revised supplemental New Drug Application for IZERVAY
The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.