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INSIGHTS+

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…
Disease of the Month – Alopecia 
Shots:  Hair loss (alopecia) is a condition that causes thinning or loss of hair on the scalp or the entire body. It can be temporary or permanent and may result from genetics, hormonal changes, medical issues, or aging    PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions that affect…
New Drug Designations – August 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 August 2025 report covers designations granted to 37 drugs and 4 medical devices, spanning 14 small molecules, 5 biologics, 7 cell and gene therapies & 4 medical devices, among others    Significant…
EMA Marketing Authorization of New Drugs in August 2025
Shots:  The EMA’s CHMP has granted approvals to 1 Biologic and 3 new chemical entities in August 2025, leading to treatments for patients and advances in the healthcare industry   The major highlighted drug was Gilead’s Yeytuo has Secured the EC’s Approval for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV    PharmaShots has compiled a list of 4…
The US FDA New Drug Approvals in August 2025  
Shots:  PharmaShots has compiled a list of US FDA-approved drugs in the month of August 2025  The US FDA has approved a total of 5 new drugs, including 5 new molecular entities, leading to the treatment of patients and advances in the pharmaceutical industry  The major highlighted drug was Jazz Pharmaceuticals’ Modeyso, securing FDA approval…
Know Your Investor: Cormorant Asset Management (September’25 Edition) 
Shots:  Welcome to the September edition of Know Your Investor, featuring leading investors fuelling healthcare & life sciences  This edition spotlights Cormorant Asset Management, an investment firm focused on biotechnology and healthcare companies  In 2024, Cormorant completed 31 investments ~$3.88B, spanning PIPEs, private financings, IPO, and venture rounds. For the full report, contact us at…
Key Biosimilars Events of August 2025  
Shots:        Biosimilars are developed to be highly similar 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         Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea). Our…
Disease of the Month – Rosacea 
Shots:  Rosacea is a chronic skin condition characterized by facial redness, acne-like breakouts, and flushing. It may cause enlarged blood vessels and small pus pus-filled bumps   PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions that affect communities worldwide. These reports provide a comprehensive overview of disease, including their…