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Ipsen Pharmaceuticals
NEWS

Ipsen Receives US FDA Breakthrough Therapy Designation for IPN60340 in Unfit Acute Myeloid Leukemia

Shots: The US FDA has granted Breakthrough Therapy Designation (BTD) to Ipsen’s investigational therapy IPN60340 (ICT01) in combination with venetoclax and azacitidine for the treatment of 1L unfit acute myeloid leukemia (AML) The designation was supported by data from the P-I/II (EVICTION) study (n=57), where IPN60340 + Ven-Aza showed encouraging response rates, including a near…
January 14, 2026

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NEWS

Orca Bio Presents New Clinical Data On Orca-Q and Orca-T/CAR-T Combination Therapy at ASH 2025

Shots: Orca Bio reported positive P-I study data for Orca-Q, showing rapid neutrophil recovery, low acute/chronic GvHD, reduced infections, and low non-relapse mortality, including in patients treated without any GvHD prophylaxis Patients receiving Orca-Q with tacrolimus (Arm A, n=18) vs. without immunosuppression (Arm C, n=26) showed comparable survival and GvHD outcomes, with faster neutrophil engraftment…
December 9, 2025

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New Drug Designations - August 2023
INSIGHTS+

New Drug Designations – August 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices  Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…
September 18, 2023

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