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BioAtla and GATC Health Announce $40M SPV Transaction to Advance Ozuriftamab Vedotin into P-III Study for 2L+ OPSCC

Shots: BioAtla and GATC Health announce  into a $40M special purpose vehicle (SPV) transaction to advance ozuriftamab vedotin (Oz-V), a CAB-ROR2-ADC, into a registrational P-III study for 2L+ oropharyngeal squamous cell carcinoma (OPSCC) Under the agreement, BioAtla will receive $5M upfront to support operations and P-III study execution, with the remaining $35M expected to close…
January 2, 2026

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Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Shots: The US FDA has granted FTD to HMI-115 for the treatment of mod. to sev. pain associated with endometriosis Designation was based on the global P-II dose-finding study assessing HMI-115 vs PBO for 12wks. in 108 females with surgically diagnosed endometriosis across the US, Poland & China, showing significant improvement Trial showed that HMI-115…
December 5, 2025

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Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma

Shots: The US FDA has granted FTD to zotiraciclib (ZTR/TG02) for the treatment of pts with recurrent high-grade gliomas (rHGG) harboring IDH1 or IDH2 mutations (IDHmut rHGG) Designation was backed by the completion of the P-I trial of zotiraciclib, showing preliminary efficacy & favorable safety as a monotx. in IDHmut rHGG pts, which was presented at…
November 27, 2025

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INSIGHTS+

New Drug Designations – September 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 September 2025 report covers designations granted to 33 drugs and 4 medical devices, spanning 12 small molecules, 6 biologics, 8 cell and gene therapies & 4 medical devices among others  …
October 28, 2025

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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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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 stroke Designation 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 onset Additionally, 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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