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NEWS

Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

Shots:The US FDA has granted FTD to alnodesertib + low-dose irinotecan as the 3L treatment of adults with ATM-negative metastatic colorectal cancer (mCRC)Designation was based on the P-I/II (STELLA) trial (ongoing in the US) assessing the regimen in solid tumors with ATM deficiency, which showed responses in 3L mCRC & 7 additional solid…
September 25, 2025

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NEWS

The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Shots:The US FDA has granted FTD to RNS60 (oxygen-enriched saline) for the treatment of acute ischemic strokeDesignation was based on extensive preclinical data & P-II (RESCUE) trial, which showed reduced brain tissue loss, improved functional outcomes, & shorter hospital stays in pts treated within 24 hours of stroke onsetAdditionally, Revalesio is planning…
August 4, 2025

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INSIGHTS+

New Drug Designations – May 2025  

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA   The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others   …
June 24, 2025

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INSIGHTS+

New Drug Designations – April 2025  

Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA  The April 2025 report covers designations granted to 36 drugs and 6 medical devices, spanning 14 small molecules, 3 biologics, 11 cell and gene therapies & 6 medical devices among…
May 27, 2025

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NEWS

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

Shots:The US FDA has granted FTD to SGT-212 for treating Friedreich’s ataxia (FA) and previously approved its IND on Jan 07, 2025 The P-Ib study will assess safety & tolerability of contemporaneous systemic IV and bilateral IDN administration of SGT-212 in non-ambulatory and ambulatory FA patients for 5yrs., with dosing anticipated during H2’25…
January 22, 2025

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New Drug Designations - October 2024
INSIGHTS+

New Drug Designations – October 2024

Shots:  PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, NMPA, and EMA  The October 2024 report covers designations granted to 33 drugs and 2 devices, encompassing 14 small molecules, 4 biologics, 8 cell and gene therapies, and 2 medical devices. Significant trends this month…
November 26, 2024

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New Drug Designations - September 2024
INSIGHTS+

New Drug Designations – September 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA, Health Canada and EMA. The September 2024 report covers regulatory designations for 42 drugs and 1 device, including 16 small molecules, 6 biologics, 12 cell and gene therapies, and 1 device, among others. Significant trends this month…
October 29, 2024

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Exclusive_Chris Heery_2024
EXCLUSIVE

Advancing Care for Hematologic Malignancies: Chris Heery from Arcellx in a Stimulating Dialogue Exchange with PharmaShots

Shots: Arcellx’s Anito-cel, a BCMA CAR-T therapy recently got the FTD, ODD, RMAT designations by the FDA for the treatment of patients with relapsed or refractory multiple myeloma (r/rMM) Today, at PharmaShots we have Chris Heery, Chief Medical Officer at Arcellx, shedding light on Anito-Cel therapy in advancing care for multiple myeloma In late 2022,…
September 30, 2024

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