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RSS FeedPosted by Michael Wonder on 22 Dec 2023
Keytruda (pembrolizumab) plus Lenvima (lenvatinib) receive public listing for patients with advanced endometrial carcinoma that is not MSI-H or dMMR
21 December 2023 - Merck and Eisai announce that Keytruda plus Lenvima, is now reimbursed with clinical criteria and conditions ...
Posted by Michael Wonder on 21 Dec 2023
Janssen submits marketing authorisation application to the EMA seeking approval of lazertinib, in combination with Rybrevant (amivantamab), for the first-line treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...
Posted by Michael Wonder on 21 Dec 2023
Johnson & Johnson submits supplemental biologics license application and new drug application to US FDA seeking approval of Rybrevant (amivantamab-vmjw) plus lazertinib for the treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - Submissions supported by data from landmark Phase 3 MARIPOSA study, which showed statistically significant and clinically meaningful ...
Posted by Michael Wonder on 20 Dec 2023
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy for new first-line indications in advanced HER2 negative gastric or GEJ adenocarcinoma in tumours expressing PD-L1 (CPS ≥1) and advanced biliary tract cancer
18 December 2023 - Keytruda now approved for 26 indications in the EU, including seven in gastro-intestinal cancers. ...
Posted by Michael Wonder on 18 Dec 2023
AnHeart Therapeutics and Innovent Announce China’s NMPA has granted taletrectinib (ROS1 inhibitor) priority review designation
18 December 2023 -AnHeart Therapeutics and Innovent Biologics today announced the Center for Drug Evaluation of China’s National Medical Products ...
Posted by Michael Wonder on 18 Dec 2023
US FDA issues complete response letter for cosibelimab solely due to inspection findings at third party manufacturer
18 December 2023 - FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability ...
Posted by Michael Wonder on 15 Dec 2023
FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer
15 December 2023 - Today, the FDA approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for ...
Posted by Michael Wonder on 15 Dec 2023
FDA approves belzutifan for advanced renal cell carcinoma
14 December 2023 - Today, the FDA approved belzutifan (Welireg, Merck) for patients with advanced renal cell carcinoma following a ...
Posted by Michael Wonder on 15 Dec 2023
Abbisko Therapeutics announces that US FDA has granted fast track designation for its CSF-1R inhibitor pimicotinib (ABSK021)
13 December 2023 - Abbisko Therapeutics today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted the fast track designation ...
Posted by Michael Wonder on 14 Dec 2023
Antengene announces inclusion of Xpovio (selinexor) in 2023 China's National Reimbursement Drug List
13 December 2023 - Antengene today announced that Xpovio (selinexor) has been added to the National Reimbursement Drug List (2023 Version) ...
Posted by Michael Wonder on 14 Dec 2023
FDA grants priority review to Amgen's tarlatamab application for advanced small cell lung cancer
13 December 2023 - FDA target action date is 12 June 2024. ...
Posted by Michael Wonder on 14 Dec 2023
FDA approves eflornithine for adult and paediatric patients with high-risk neuroblastoma
13 December 2023 - Today, the FDA approved eflornithine (Iwilfin) to reduce the risk of relapse in adult and paediatric ...
Posted by Michael Wonder on 13 Dec 2023
Hutchmed announces continued inclusion of Elunate (fruquintinib) and Sulanda (surufatinib) in the National Reimbursement Drug List in China at current terms
12 December 2023 - Hutchmed today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration, ...
Posted by Michael Wonder on 13 Dec 2023
Pembrolizumab and chemotherapy with or without bevacizumab for patients with persistent, recurrent or metastatic cervical cancer
13 December 2023 - NICE has published final evidence-based recommendations on the use of pembrolizumab (Keytruda) and chemotherapy with or ...
Posted by Michael Wonder on 12 Dec 2023
Candel Therapeutics receives FDA fast track designation for CAN-2409 in pancreatic cancer
12 December 2023 - Candel Therapeutics today announced that the US FDA granted fast track designation for its lead investigational adenovirus ...