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% complete response in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.
Johnson & Johnson Initiates IND Submission Of TAR-200 To Treat High-risk Bladder Cancer
Wednesday said it has initiated the submission of new drug application or NDA to Food and Drug Administration (FDA) for TAR-200 to treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...
A non-opioid painkiller from Vertex Pharmaceuticals could become a blockbuster, but questions remain on whether it will prove ...
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...
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 ...
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
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 received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
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 ...
The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.
has accepted and granted priority review to the company's New Drug Application (NDA) for sunvozertinib, an oral EGFR inhibitor for the treatment of locally advanced or metastatic non-small cell ...
INCHEON, South Korea, Jan. 15, 2025 /PRNewswire/ — Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, ...
The investigational new drug application for the nanoparticle drug SNB-101 has been cleared for small cell lung cancer ...
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