Blog
RSS FeedPosted by Michael Wonder on 30 Jan 2025
Depemokimab applications accepted for review in China and Japan for asthma with type 2 inflammation and CRSwNP
28 January 2025 - Submissions based on data from positive SWIFT and ANCHOR trials. ...
Posted by Michael Wonder on 21 Jan 2025
Anti-PD-L1 tagitanlimab approved for marketing by the National Medical Products Administration
20 January 2025 - The board of directors of Sichuan Kelun-Biotech Biopharmaceutical is pleased to announce that the Company received ...
Posted by Michael Wonder on 17 Jan 2025
Senaparib approved by NMPA for first-line maintenance therapy in ovarian cancer
16 January 2025 - Impact Therapeutics is pleased to announce that senaparib capsules has received marketing authorisation in China from ...
Posted by Michael Wonder on 15 Jan 2025
Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma
13 January 2025 - Approval based on positive pivotal ICARIA-MM Phase 3 study using the China-based IsaFiRsT real world study as ...
Posted by Michael Wonder on 13 Jan 2025
Bayer submits application to US FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need
10 January 2025 - Regulatory submissions are based on positive data from the Phase 3 FINEARTS-HF study recently presented at ESC ...
Posted by Michael Wonder on 08 Jan 2025
China's National Medical Products Administration approves Padcev in combination with Keytruda (pembrolizumab) for the treatment of advanced bladder cancer
8 January 2025 - NMPA approval based on the global Phase 3 EV-302 trial (also known as KEYNOTE-A39) where the ...
Posted by Michael Wonder on 07 Jan 2025
Nuvation Bio receives approval from China’s National Medical Products Administration for taletrectinib for patients with advanced ROS1 positive non-small cell lung cancer
6 January 2025 - Taletrectinib will be marketed in China by Innovent Biologics. ...
Posted by Michael Wonder on 06 Jan 2025
China's National Medical Products Administration approves Vyloy (zolbetuximab) for first-line treatment of advanced gastric or gastro-oesophageal junction adenocarcinoma
5 January 2024 - Treatment with the claudin 18.2 targeted monoclonal antibody shown to significantly extend both progression-free survival and ...
Posted by Michael Wonder on 03 Jan 2025
GSK’s Nucala (mepolizumab) approved in China for treatment of adults with chronic rhinosinusitis with nasal polyps
3 January 2025 - This is the third indication for mepolizumab in China for an IL-5 mediated condition. ...
Posted by Michael Wonder on 03 Jan 2025
Innovent announces second new drug pplication of Dovbleron (taletrectinib adipate capsule, ROS1 inhibitor) was approved by China's National Medical Products Administration
2 January 2025 - Innovent Biologics today announced that China's National Medical Products Administration has approved the second new drug application ...
Posted by Michael Wonder on 19 Dec 2024
Lilly's Kisunla (donanemab-azbt) approved in China for the treatment of early symptomatic Alzheimer's disease
17 December 2024 - China is the fourth major market where Kisunla has received approval. ...
Posted by Michael Wonder on 05 Dec 2024
Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan approved for marketing by NMPA of China for second-line advanced or metastatic triple negative breast cancer
27 November 2024 - Sichuan Kelun-Biotech Biopharmaceutical announced that the Company received marketing authorisation in China from the NMPA for the ...
Posted by Michael Wonder on 14 Oct 2024
Enhertu approved in China as first HER2 directed therapy for patients with HER2 mutant metastatic non-small cell lung cancer
14 October 2024 - Approval based on DESTINY-Lung02 and DESTINY-Lung05 results which showed Enhertu demonstrated clinically meaningful efficacy in previously ...
Posted by Michael Wonder on 28 Sep 2024
Dupixent (dupilumab) approved in China as the first ever biologic medicine for patients with chronic obstructive pulmonary disease
27 September 2024 - Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based ...
Posted by Michael Wonder on 24 Sep 2024
Japan's Ministry of Health, Labour and Welfare approves Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of radically unresectable urothelial carcinoma
24 September 2024 - Approval based on the EV-302 trial where the treatment combination nearly doubled median overall survival and significantly ...