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News about "Breakthrough Therapy Designation "
FDA Grants BTD to Raludotatug Deruxtecan for Platinum-Resistant Ovarian Cancer
This is the first BTD granted for Raludotatug Deruxtecan, the second for the Daiichi Sankyo-Merck partnership and the 15th across Daiichi Sankyo’s oncology portfolio, marking a significant milestone in the companies’ joint efforts to develop innovative cancer therapies.
Breakthrough Therapy Designation | 16/09/2025 | By Dineshwori
AstraZeneca's Imfinzi Granted Priority Review by FDA for Early-Stage Gastric and GEJ Cancers
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) and granted Priority Review for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
Breakthrough Therapy Designation | 28/07/2025 | By Dineshwori
Arrowhead Pharmaceuticals Secures FDA Breakthrough Therapy Designation for Plozasiran
Arrowhead intends to submit a New Drug Application to the FDA by year-end 2024 and plans to seek regulatory approval with additional global regulatory authorities thereafter.
Breakthrough Therapy Designation | 13/09/2024 | By Aishwarya | 393
AusperBio Gets BTD for AHB-137 in Chronic Hepatitis B Treatment
AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. have announced that their investigational drug AHB-137 has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.
Breakthrough Therapy Designation | 11/07/2024 | By Aishwarya | 450
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