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INSIGHTS+

Key Biosimilars Events of November 2025  
Shots:        Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma  Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…
December 2, 2025
Disease of the Month – Telangiectasia 
Shots:  Telangiectasia refers to the presence of small, visible red blood vessels, often called broken capillaries, that appear close to the surface of the skin. While common, they are often misunderstood, making awareness and early understanding essential  At PharmaShots, our Disease of the Month report is crafted to make complex medical information accessible and relevant…
November 26, 2025
New Drug Designations – October 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 October 2025 report covers designations granted to 56 drugs and 9 medical devices, spanning 23 small molecules, 14 biologics, 10 cell and gene therapies & 9 medical devices, among…
November 25, 2025
EMA Marketing Authorization of New Drugs in October 2025  
Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In October, the EMA issued positive CHMP opinions for two significant therapies: Sanofi’s Wayrilz (rilzabrutinib) for adults with immune thrombocytopenia, and Insmed’s Brinsupri (brensocatib) for the…
November 18, 2025
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…
November 11, 2025
Know Your Investor: Samsara Biocapital (November’25 Edition)  
Shots:  Samsara Biocapital is a California-based venture capital and registered investment adviser investing across early to post-IPO stages in healthcare, life sciences, oncology, and digital health, with a portfolio of 70+ companies including Scholar Rock and PepGen  The firm made 30 investments across PIPE (43%), Series B (23%), and other rounds, with notable deals such…
November 5, 2025
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…
November 4, 2025
Disease of the Month – Paroxysmal nocturnal hemoglobinuria (PNH) 
Shots:  Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired blood disorder where the body's immune system attacks and destroys red blood cells and platelets  PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions that affect communities worldwide.   This report provides a comprehensive overview of disease, including its characteristics,…
October 29, 2025
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
EMA Marketing Authorization of New Drugs in September 2025  
Shots:  The EMA’s CHMP has granted approvals to 5 Biologics and 5 new chemical entities in September 2025, leading to treatments for patients and advances in the healthcare industry    The major highlighted drug, Merck’s Enflonsia, has Adopted Positive Opinion for RSV Prevention in Infants    PharmaShots has compiled a list of 9 drugs that have been…
October 21, 2025
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