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RSS FeedPosted by Michael Wonder on 02 Jun 2025
Kura Oncology and Kyowa Kirin announce FDA acceptance and priority review of new drug application for ziftomenib in adults with relapsed or refractory NPM1 mutant AML
1 June 2025 - New drug application based on positive results from the Phase 2 KOMET-001 trial. ...
Posted by Michael Wonder on 29 May 2025
Patritumab deruxtecan biologics license application for patients with previously treated locally advanced or metastatic EGFR mutated non-small cell lung cancer voluntarily withdrawn
29 May 2025 - The biologics license application seeking accelerated approval in the US for Daiichi Sankyo and Merck's patritumab ...
Posted by Michael Wonder on 28 May 2025
Experimental Drug Development Centre granted US FDA fast track designation for antibody-drug conjugate EBC-129 to treat pancreatic ductal adenocarcinoma
28 May 2025 - EBC-129 is the first made in Singapore antibody-drug conjugate to enter clinical development. ...
Posted by Michael Wonder on 28 May 2025
Candel Therapeutics receives FDA regenerative medicine advanced therapy designation for CAN-2409 for the treatment of prostate cancer
28 May 2025 - Candel Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to CAN-2409 ...
Posted by Michael Wonder on 28 May 2025
US FDA accepts new drug application under priority review for sevabertinib (BAY 2927088) in HER2 mutant non-small cell lung cancer
28 May 2025 - Regulatory submission is based on positive results from the on-going Phase I/II SOHO-01 trial in patients with ...
Posted by Michael Wonder on 28 May 2025
New subcutaneous formulation of Opdivo approved in Canada for use across all authorised solid tumour indications
27 May 2025 - Subcutaneous option of established immunotherapy offers potential to reduce time in clinic and ease infusion burden. ...
Posted by Michael Wonder on 27 May 2025
Imfinzi recommended for approval in the EU by CHMP as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
27 May 2025 - Recommendation based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 27 May 2025
Schedule rule changes will improve continuity of cancer care
23 May 2025 - PHARMAC is proposing a change to the Pharmaceutical Schedule rules, which if agreed, would give New ...
Posted by Michael Wonder on 25 May 2025
CHMP recommends EU approval of Roche’s Itovebi for PIK3CA mutated, ER positive, HER2 negative, advanced breast cancer
23 May 2025 - Positive recommendation based on Phase 3 INAVO120 data showing Itovebi (inavolisib) in combination with palbociclib and fulvestrant ...
Posted by Michael Wonder on 22 May 2025
Dostarlimab with platinum-based chemotherapy for treating primary advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency
22 May 2025 - Dostarlimab, when used in combination with platinum-based chemotherapy, can be used as an option for the ...
Posted by Michael Wonder on 22 May 2025
PharmaMar has submitted EU marketing authorization application for lurbinectedin in combination with atezolizumab in first-line maintenance therapy for extensive-stage small cell lung cancer
21 May 2025 - PharmaMar has submitted a marketing authorisation application to the EMA for Zepzelca (lurbinectedin) in combination with ...
Posted by Michael Wonder on 22 May 2025
Tagrisso approved (with conditions) in Canada for patients with unresectable, stage III EGFR-mutated non-small cell lung cancer
21 May 2025 - Based on LAURA Phase 3 trial results which showed patients who took Targrisso after CRT had ...
Posted by Michael Wonder on 19 May 2025
Zai Lab receives US FDA fast track designation for ZL-1310, a DLL3 targeted antibody drug conjugate, for treatment of extensive stage small cell lung cancer
19 May 2025 - The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung ...
Posted by Michael Wonder on 16 May 2025
BMS receives European Commission approval for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by adjuvant Opdivo for resectable, high risk non-small cell lung cancer with PD-L1 expression ≥1%
16 May 2025 - Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared ...
Posted by Michael Wonder on 16 May 2025
FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal
15 May 2025 - Today, the FDA approved retifanlimab-dlwr (Zynyz, Incyte) with carboplatin and paclitaxel for the first-line treatment of ...