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The US FDA New Drug Approvals in October 2025 

Shots:  Innovation in drug development continues to shape the future of healthcare, driving bold scientific collaborations and transforming the way diseases are treated across every frontier of medicine  In October, the US FDA granted approvals to Boehringer Ingelheim’s Jascayd (nerandomilast) for adults with idiopathic pulmonary fibrosis and Bayer’s Lynkuet (elinzanetant) for managing moderate to severe…

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Key Biosimilars Events of October 2025  

Shots:        Biosimilars are developed to match approved biologic therapies in safety, and efficacy, ensuring comparable clinical outcomes. They represent a critical pathway to reducing healthcare costs by providing affordable alternatives to expensive branded biologics, delivering meaningful savings for both patients and payers  In a key development, Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives the US FDA’s Approval…

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Key Biosimilars Events of December 2024

Key Biosimilars Events of December 2024

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…

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Key Biosimilars Events of December 2024

Key Biosimilars Events of December 2024

Shots:       Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…

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Viewpoints_Baldo Scassellati Sforzolini

Unlocking Approval: Baldo Scassellati Sforzolini from Galderma in a Stimulating Dialogue Exchange with PharmaShots

Shots:  Galderma’s Nemluvio (nemolizumab) was recently approved by the US FDA for the treatment of adults with prurigo nodularis, following positive Phase III results from the OLYMPIA study.  Today at PharmaShots, we have Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma, to discuss the study’s design and the potential of Nemluvio in…

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Insights+ Key Biosimilars Events of April 2024

Insights+ Key Biosimilars Events of April 2024

Shots:    Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency     Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients     During April, Samsung Bioepis and Sandoz received the EC’s Marketing Authorization approval for Pyzchiva.…

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Insights+ Key Biosimilars Events of March 2024

Insights+ Key Biosimilars Events of March 2024

Shots:   Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency    Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients    During March, Sandoz received the US FDA’s approval for Wyost & Jubbonti.…

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