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RSS FeedPosted by Michael Wonder on 08 Jan 2025
US FDA granted priority review to Dizal's sunvozertinib new drug application
7 January 2025 - Sunvozertinib's new drug application was submitted based on the multinational pivotal WU-KONG1 Part B study, the ...
Posted by Michael Wonder on 07 Jan 2025
GSK’s B7-H3 targeted antibody drug conjugate, GSK’227, receives US FDA breakthrough therapy designation in late-line relapsed or refractory osteosarcoma
7 January 2025 - Regulatory designation based on promising early data in this rare bone cancer. ...
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
Enfortumab vedotin plus pembrolizumab in advanced bladder cancer: evidence of a significant additional benefit
2 January 2025 - Patients for whom cisplatin-based therapy is unsuitable live significantly longer with the new combination of active ingredients ...
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
New Zealand Pharmaceutical Schedule - 1 January 2025
1 January 2025 - The January 2025 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
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 01 Jan 2025
European Commission approves Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
30 December 2024 - In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced the risk of disease progression or ...
Posted by Michael Wonder on 01 Jan 2025
Tarlatamab approved to treat adult patients with small cell lung cancer
31 December 2024 - The MHRA has today approved the medicine tarlatamab (Imdyllytra) to treat adult patients with small cell lung ...
Posted by Michael Wonder on 31 Dec 2024
Verastem Oncology announces FDA acceptance and priority review of new drug application for avutometinib in combination with defactinib for the treatment of recurrent KRAS mutant low grade serous ovarian cancer
30 December 2024 - PDUFA target action date is 30 June 2025. ...
Posted by Michael Wonder on 27 Dec 2024
FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
27 December 2024 - Today, the FDA approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous injection across ...
Posted by Michael Wonder on 27 Dec 2024
Datroway approved in Japan as the first TROP-2 directed therapy for patients with previously treated unresectable or recurrent hormone receptor positive, HER2 negative breast cancer
27 December 2024 - First global approval based on TROPION-Breast01 where Datroway significantly reduced the risk of disease progression or ...
Posted by Michael Wonder on 24 Dec 2024
Datopotamab deruxtecan application in the EU for patients with advanced non-squamous non-small sell lung cancer voluntarily withdrawn
24 December 2024 - Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorisation application in the EU for datopotamab ...
Posted by Michael Wonder on 24 Dec 2024
US FDA accepts for priority review Nuvation Bio’s new drug application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer
23 December 2024 - New drug application is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies ...
Posted by Michael Wonder on 23 Dec 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer
23 December 2024 - Approval based on results of the Phase 3 CheckMate-8HW trial, in which the dual immunotherapy combination ...