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,…
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…
Shots:
Kashiv BioSciences submitted a BLA to the US FDA and received EMA MAA acceptance for ADL-018, a proposed biosimilar to Xolair (omalizumab)
ADL-018 is a humanized mAb biosimilar to Xolair (omalizumab), designed to block IgE binding on mast cells and basophils. Xolair is approved for CSU (≥12 yrs), moderate-to-severe asthma (≥6 yrs), chronic rhinosinusitis…

