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New Drug Designations: July 2025
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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…
August 26, 2025

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FDA Drug Approvals May 2025
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The US FDA New Drug Approvals in May 2025

Shots:      PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2025       The US FDA has approved a total of 3 new drugs, including 2 new molecular entities and 1 Biologic leading to the treatment of patients and advances in the healthcare industry        The major highlighted drug was AbbVie’s Emrelis securing…
June 10, 2025

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Top biosimilar news of the Apr 2025
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Key Biosimilars Events of April 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         Henlius Collaborates with Sandoz for the Commercialization of HLX13. Our team at PharmaShots…
May 6, 2025

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Key Biosimilars Events of March 2025
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Key Biosimilars Events of March 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         Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 & BAT2506…
April 8, 2025

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