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Telix’s Pixclara NDA Accepted By US FDA, Review Underway For Glioma Imaging Agent With September 2026 Decision Timeline
Telix Pharmaceuticals Limited NDA for Pixclara (TLX101-Px) accepted by FDA for glioma imaging, with PDUFA date set for September 2026 to support brain cancer diagnosis.
Vaibhavi M.
Glenmark Secures US FDA Approval For Progesterone Vaginal Inserts, Expands Presence In $59.2 Million Market
Glenmark Pharmaceuticals Limited secures FDA approval for progesterone vaginal inserts 100 mg, a generic of Endometrin, to treat infertility-related conditions in women’s health.
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ANI Pharmaceuticals Launches Generic Isosorbide Mononitrate Tablets For Angina Treatment, Following FDA Approval
ANI Pharmaceuticals launches generic Isosorbide Mononitrate tablets for angina treatment following FDA approval, expanding access to affordable nitrate therapy options.
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Plus Therapeutics Secures FDA Orphan Drug Designation For REYOBIQ In Pediatric Brain Tumours
Plus Therapeutics gains FDA Orphan Drug Designation for REYOBIQ in pediatric malignant gliomas and ependymoma, advancing targeted radiotherapy for rare brain tumors.
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