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Good News in the Anti-AβAntibodies Field, Two Drugs were Successively Granted Breakthrough Drug Qualification by the FDA PharmaSources/Dopine
July 13, 2021
Two AD drugs have been granted BTD by the FDA recently, namely Eisai/Biogen's Lecanemab (BAN2401) and Eli Lilly's Donanemab.
NRx seeks breakthrough therapy designation for Covid-19 treatment Pharmaceutical-Technology
January 04, 2022
In a randomised trial, the therapy demonstrated a statistically significant two-fold increased odds of survival.
AbbVie’s Teliso-V Granted BTD in NSCLC contractpharma
January 04, 2022
For the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC).
Breakthrough designation granted for Amgen’s bemarituzumab pharmatimes
April 21, 2021
Amgen’s investigational medicine bemarituzumab has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA).
Junshi Biosciences gets US FDA Breakthrough Therapy Designation for Toripalimab to treat nasopharyngeal carcinoma expresspharma
September 14, 2020
Chinese firm, Junshi Biosciences announced that the US Food and Drug Administration (FDA) has recently granted Breakthrough Therapy designation (BTD) to Toripalimab for the treatment of nasopharyngeal carcinoma.
Viela Bio Receives FDA Breakthrough Therapy Designation for Inebilizumab americanpharmaceuticalreview
April 22, 2019
Viela Bio Receives FDA Breakthrough Therapy Designation for Inebilizumab...
AZ’s Selumetinib granted US Breakthrough Therapy Designation pharmatimes
April 02, 2019
AstraZeneca and MSD have announced the granting of Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for its MEK 1/2 inhibitor and potential new medicine selumetinib.
US and European regulatory agencies fast track AstraZeneca’s RSV drug pharmaceutical-technology
February 19, 2019
AstraZeneca and its division MedImmune have secured fast tract status for their respiratory syncytial virus (RSV) therapeutic, MEDI8897, from both the US and European regulatory authorities....
AstraZeneca announces that Tagrisso granted breakthrough therapy designation (BTD) by US FDA pharmaasia
October 17, 2017
Tagrisso is a first-line treatment for EGFR mutation-positive non-small cell lung cancer. This is the sixth BTD for an AstraZeneca New Oncology medicine.