- HUTCHMED Receives Breakthrough Therapy Designation in China ...🔍
- FDA Grants Breakthrough Therapy Designation to Sunvozertinib for ...🔍
- Bayer Receives Breakthrough Therapy Designation in China for ...🔍
- Nanjing Leads Biolabs Achieves Breakthrough Therapy Designation ...🔍
- FDA Grants Breakthrough Therapy Designation to Sunvozertinib in ...🔍
- Press Release🔍
- The BCMA CAR|T Co|developed by IASO Biotherapeutics and ...🔍
- Boehringer receives U.S. FDA Breakthrough Therapy🔍
The Breakthrough Therapy Designation in China
HUTCHMED Receives Breakthrough Therapy Designation in China ...
HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer.
pCAR-19B, Independently Developed by Precision Biotech, Granted ...
pCAR-19B, as the first CAR-T product with this indication entering the critical clinical research stage in China, was included in Breakthrough Therapy ...
FDA Grants Breakthrough Therapy Designation to Sunvozertinib for ...
Sunvozertinib was previously granted BTDs by both the US FDA and the China Center for Drug Evaluation (CDE) for relapsed or refractory patients ...
Bayer Receives Breakthrough Therapy Designation in China for ...
Bayer announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy ...
Nanjing Leads Biolabs Achieves Breakthrough Therapy Designation ...
On 9 October 2024, Nanjing Leads Biolabs announced that China's Center for Drug Evaluation of National Medical Products Administration ...
APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia ... Apollomics, Inc. GlycoMimetics, Inc.
FDA Grants Breakthrough Therapy Designation to Sunvozertinib in ...
In China, sunvozertinib was granted approval in 2023 for the treatment of patients who progressed on first-line treatment. New drug application ...
Press Release - AnHeart Therapeutics
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with ...
The BCMA CAR-T Co-developed by IASO Biotherapeutics and ...
NMPA grants Breakthrough Therapy Designation to new medicines that are intended to treat serious conditions and where clinical evidence ...
Boehringer receives U.S. FDA Breakthrough Therapy
The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated ...
'Breakthrough therapy': a new Chinese drug shows record treatment ...
In a phase 2 clinical trial that enrolled 104 advanced patients and analysed 97 cases, a new drug called sunvozertinib could reportedly achieve ...
Cilta-cel for Multiple Myeloma Named Breakthrough Therapy in China
“Breakthrough designation recommendation by the China CDE of NMPA represents an important regulatory milestone in the continued development of ...
IMFINZI was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and ...
GSK : Blenrep Combination Receives Breakthrough Therapy ...
... China has granted Breakthrough Therapy Designation to Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone or BorD.
Belantamab Mafodotin + Bortezomib plus Dexamethasone Receives ...
Belantamab Mafodotin + Bortezomib plus Dexamethasone Receives Breakthrough Therapy Designation in China for r/r Multiple Myeloma » ADC ...
Novartis receives FDA Breakthrough Therapy designation for ...
Novartis announced that the FDA has granted Breakthrough Therapy designation to Scemblix® (asciminib) for the treatment of adult patients with newly diagnosed ...
AusperBio AHB-137 gains breakthrough status in China for CHB
AusperBio Therapeutics and Ausper Biopharma have gained breakthrough therapy designation (BTD) in China for their investigational drug, AHB-137, to treat ...
HUTCHMED Receives Breakthrough Therapy Designation from ...
13, 2021, that China's National Medical Products Administration granted breakthrough therapy designation (BTD) for amdizalisib (HMPL-689) for ...
Bayer receives Breakthrough Therapy designation in China for BAY ...
"The Breakthrough Therapy designations granted for BAY 2927088 by China's CDE and the U.S. FDA underscore the potential of this targeted therapy ...
GSK on X: "#News for #Investors and #Media: China's National ...
... Breakthrough Therapy Designation for one of our #bloodcancer therapies in combination with standards of care: https://t.co/6ESxwWQnvv.