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New Drug Designations: July 2025
New Drug Designations: July 2025
Shots:       PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA.    The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…
EMA Marketing Authorization of New Drugs in July 2025  
Shots:  The EMA’s CHMP has granted positive opinions and approvals to 3 Biologics and 10 new chemical entities in July 2025, leading to treatments for patients and advances in the healthcare industry   The major highlighted drug was Roche’s Itovebi Secures the EC’s Approval for PIK3CA-mutated Breast Cancer    PharmaShots has compiled a list of 13 drugs…
The US FDA New Drug Approvals in July 2025  
Shots:  PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2025  The US FDA has approved a total of 6 new drugs, including 5 new molecular entities and 1 biologic, leading to the treatment of patients and advances in the pharmaceutical industry  The major highlighted drug was Regeneron’s Lynozyfic, securing…
Know Your Investor: Venrock Healthcare Capital Partners (August’25 Edition)   
Shots:     Welcome to the August edition of Know Your Investor, featuring leading venture capital firms fuelling innovation in healthcare and life sciences  This edition spotlights Venrock Healthcare Capital Partners, a venture capital fund focused on investments in both publicly and privately held healthcare companies  In 2024, Venrock Healthcare Capital Partners invested approximately $4.56B across six…
Key Biosimilars Events of July 2025  
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         Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the…
Disease of the Month – Urticaria
Shots:  Characterized by an itchy skin rash, urticaria, commonly known as hives, is often triggered by allergic reactions to food, medications, or contact with irritants.   PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions affecting communities across the globe. This monthly feature provides a comprehensive overview of each disease,…
New Drug Designations: June 2025 
Shots:      PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA   The June 2025 edition covers designations awarded to 43 drugs and 3 medical devices, comprising 17 small molecules, 7 biologics, 8 cell and gene therapies, and…
EMA Marketing Authorization of New Drugs in June 2025  
Shots:  The EMA’s CHMP has granted positive opinions and approvals to 2 Biologics and 6 new chemical entities in June 2025, leading to treatments for patients and advances in the healthcare industry   The major highlighted drug was SpringWorks Therapeutics’ Ogsiveo to Treat Desmoid Tumours  PharmaShots has compiled a list of 8 drugs that have been…
Know Your Investor: Invus (July’25 Edition)
Shots:      Welcome to the 2025 edition of Know Your Investor, highlighting leading venture capital firms shaping the future of healthcare innovation  This edition highlights Invus, an investment firm focused on supporting life sciences companies committed to advancing breakthroughs that enhance public health  In 2024, Invus invested around $4.15B across six funding rounds, expanding its portfolio…
The US FDA New Drug Approvals in June 2025  
Shots:  PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2025  The US FDA has approved a total of 5 new drugs, including 2 new molecular entities and 3 biologics, leading to the treatment of patients and advances in the pharmaceutical industry  The major highlighted drug was Daiichi Sankyo and AstraZeneca’s Datroway, securing…