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Insight+_Ridhi Rastogi

New Drug Designations – March 2025 

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA    The March 2025 report covers designations granted to 37 drugs and 3 medical devices, spanning 11 small molecules, 10 biologics, 10 cell and gene therapies & 3 medical devices among…

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New Drug Designations - February 2025

New Drug Designations – February 2025

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA   The February 2025 report covers designations granted to 53 drugs and 4 medical devices, spanning 16 small molecules, 14 biologics, 18 cell and gene therapies & 4 medical devices among…

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GSK

The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The FDA has accepted review application for BLA of depemokimab as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP (PDUFA: Dec 16, 2025), based on P-III (SWIFT & ANCHOR) trials, respectively SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

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New Drug Designations - January 2025

New Drug Designations – January 2025

Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA  The January 2025 report covers designations granted to 53 drugs and 9 medical devices, spanning 18 small molecules, 13 biologics, 13 cell and gene therapies & 9 medical devices among…

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Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Shots: The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25 AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…

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New Drug Designations - December 2024

New Drug Designations – December 2024

Shots:   PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, MHLW and NMPA   The December 2024 report covers designations granted to 43 drugs and 3 devices, encompassing 13 small molecules, 10 biologics, 7 cell and gene therapies & 3 medical devices among others  Significant…

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New Drug Designations - November 2024

New Drug Designations – November 2024

Shots:   PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, and NMPA   The November 2024 report covers designations granted to 28 drugs and 3 devices, encompassing 9 small molecules, 6 biologics, 7 cell and gene therapies as well as 3 medical devices  Significant trends…

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Exclusive_Chris Heery_2024

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,…

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