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INSIGHTS+

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…
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…
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…
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,…
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  …
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…
Know Your Investor: Google Ventures (October’25 Edition) 
Shots: Welcome to the October edition of Know Your Investor, spotlighting leading investors shaping the future of healthcare and life sciences This month, we feature Google Ventures (GV), the venture capital arm of Alphabet. GV actively invests across seed to growth-stage companies, spanning sectors such as software, internet, healthcare, life sciences, and artificial intelligence For…
The US FDA New Drug Approvals in September 2025  
Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of September 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 Merck’s Keytruda Qlex,…
Key Biosimilars Events of September 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, Henlius and Organon secured U.S. FDA approval for Bildyos…
PharmaShots’ Key Highlights of Third Quarter 2025 
Shots: Q3’25 was marked by major pharma and biotech M&A, led by BD’s $17.5B Reverse Morris Trust deal merging its Biosciences & Diagnostic Solutions unit with Waters, and Merck’s ~$10B acquisition of Verona Pharma The quarter spotlighted collaborations, notably GSK’s ~$12.5B agreement with Hengrui Pharma to co-develop up to 12 novel therapies across multiple disease areas. PharmaShots brings…