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NEWS

Tempest Therapeutics Enters Exclusive Option Agreement with Senlang for In Vivo CAR-T Platform and Pipeline

Shots: Senlang has granted Tempest an exclusive option to license its CD7-targeted lentiviral vector platform & in vivo CAR-T portfolio, incl. a BCMA/GPRC5D dual-targeting candidate for R/R MM & additional assets for hematologic malignancies & autoimmune diseases Senlang’s platform uses targeted lentiviral vectors to deliver CAR transgenes to endogenous CD7+ T cells and NK cells,…
September 16, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in August 2026

Shots:  The European Commission (EC) approved Daybu (trofinetide) and Hopledo (modified-release levodopa/carbidopa) for neurological disorders, expanding treatment options for Rett syndrome and Parkinson’s disease, respectively.  Daybu was approved for neurobehavioral symptoms of Rett syndrome in patients aged ≥5 years, while Hopledo was approved for adults with Parkinson’s disease and moderate to severe motor fluctuations.  The…
September 15, 2026

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NEWS

Cebreo Medical Reports CE Mark Approval of NeuroBuds for Ambulatory EEG Monitoring

Shots: Cebreo Medical has reported the CE Mark approval of its NeuroBuds device to be used unassisted by the patient at home for extended, ambulatory electroencephalogram (EEG) monitoring NeuroBuds, designed to resemble a hearing aid, minimizes the stigma & burden of long-term EEG monitoring, enabling comfortable, unassisted use for ~3mos. with repeat measurements Cebreo Medical…
September 15, 2026

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NEWS

QurCan Therapeutics Partners with Eli Lilly to Develop Nucleic Acid Therapies for CNS and PNS Diseases

Shots: QurCan Therapeutics has entered into an exclusive research & collaboration agreement with Eli Lilly for the treatment of diseases of the central nervous system (CNS) and peripheral nervous system (PNS) Lilly & QurCan will collaborate on multiple research programs focused on the development of PLNP-enabled genetic medicines for CNS & PNS delivery, with QurCan…
September 15, 2026

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NEWS

Curium Receives FDA Approval for Bexlutry to Treat GEP-NETs

Shots: The US FDA has approved Bexlutry (lutetium Lu 177 dotatate injection) for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), covering foregut, midgut, & hindgut NETs Bexlutry is a radioligand equivalent developed through the 505(b)(2) regulatory pathway, targeting Lutathera. The approval is supported by published evidence & targeted bridging data demonstrating…
September 15, 2026

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Telix Pharmaceuticals
NEWS

Telix Gains US FDA Approval for Pixclara for Brain Cancer Imaging

Shots: The US FDA has approved Pixclara (floretyrosine F 18) for pts (≥1mos.) as the FET-PET imaging drug for glioma, enabling PET imaging to help differentiate recurrent or progressive glioma from treatment-related changes Pixclara comprises a small-molecule targeting agent & fluorine-18; it binds with LAT1 & LAT2 transporters after IV administration, allowing the radioisotope’s emissions…
September 15, 2026

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NEWS

Cyllene Therapeutics Secures US FDA RMAT Designation for EG110A in Neurogenic Detrusor Overactivity

Shots: The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to EG110A to treat neurogenic detrusor overactivity (NDO) with urinary incontinence  The designation was based on the initial P-Ib/IIa trial data, ongoing in the US, in pts with NDO associated with spinal cord injury, with interim results to be presented at the ICS…
September 14, 2026

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