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Merus Receives the US FDA’s Breakthrough Therapy Designation for Petosemtamab to Treat 1L PD-L1+ Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Shots: The US FDA has granted BTD to petosemtamab + Keytruda as 1L treatment of r/m HNSCC harboring PD-L1 (CPS ≥ 1) in adults BTD was backed by interim data from ongoing P-I/II trial evaluating petosemtamab + Keytruda in mentioned pts that showed 67% response rate in 24 evaluable pts with further data presented…
February 19, 2025

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New Drug Designations - June 2024
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New Drug Designations – June 2024

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 7 small molecules, 5 biologics, 8 cell & gene therapies, 2 recombinant fusion protein, and 3 devices   This month, ChromaDex’s Nicotinamide Riboside Chloride received US FDA’s ODD &…
July 30, 2024

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New Drug Designations - May 2024
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New Drug Designations – May 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices  This…
June 25, 2024

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New Drug Designations - April 2024
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New Drug Designations – April 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices   Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…
May 30, 2024

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New Drug Designations - March 2024
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New Drug Designations – March 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices    Trellis Bioscience's…
April 30, 2024

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New Drug Designations - February 2024
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New Drug Designations – February 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, and EC. This month’s report includes designations allotted to 13 small molecules, 20 biologics, and 2 devices  SN Bioscience’s SNB-101 received ODD from the US FDA for the treatment of pancreatic cancer based on preclinical results. It…
March 28, 2024

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VIEWPOINTS_Susan Pandya_2024
VIEWPOINTS

Servier at SNO 2023: Dr. Susan Pandya Sheds Light on IDH-Mutant Diffuse Glioma Management

Shots:  In a stimulating conversation with PharmaShots, Dr. Susan Pandya shares insights from their presentation at SNO 2023 to strengthen Servier’s Neuro-Oncology Profile  While highlighting the details of vorasidenib, Susan articulately explains the study design of the P-III Indigo trial evaluating vorasidenib in patients with IDH-mutant diffuse glioma  With a fast-track designation and breakthrough therapy…
March 7, 2024

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New Drug Designations - January 2024
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New Drug Designations – January 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 13 small molecules, 7 devices, 3 biologics ADC, 3 gene therapy, 1 antineoplastics, 1 protein, 1 peptide, 1 recombinant enzyme & 1 vaccine   NRx Pharmaceuticals’ NRX-101 small molecule, focused…
February 20, 2024

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New Drug Designations - December 2023
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New Drug Designations – December 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 6 biological drugs, 10 small molecules, 5 cell and gene therapies, 1 recombinant fusion protein, 1 peptide and 2 devices   Neurocrine Biosciences’ Crinecerfont, focused on the treatment of Congenital Adrenal Hyperplasia…
January 25, 2024

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