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RSS FeedPosted by Michael Wonder on 12 Jun 2025
Gilead’s Trodelvy wins Korean coverage for breast cancer -- too late for some and still off-limits up front
12 June 2025 - It took two years, 100,000 signatures, and a wave of public pressure from patients and doctors. ...
Posted by Michael Wonder on 12 Jun 2025
Radiopharm Theranostics granted US FDA fast track designation for RAD101 imaging in brain metastases
11 June 2025 - Radiopharm Theranostics today announced that the US FDA has granted fast track designation for RAD101 to ...
Posted by Michael Wonder on 11 Jun 2025
Cantargia’s nadunolimab antibody awarded US FDA fast track designation
11 June 2025 - Cantargia today announced that the US FDA has granted fast track designation to nadunolimab, Cantargia's anti-IL1RAP antibody ...
Posted by Michael Wonder on 11 Jun 2025
FDA approves taletrectinib for ROS1 positive non-small cell lung cancer
11 June 2025 - Today, the FDA approved taletrectinib (Ibtrozi, Nuvation Bio), a kinase inhibitor, for adults with locally advanced ...
Posted by Michael Wonder on 10 Jun 2025
Zepzelca (lurbinectedin) and atezolizumab (Tecentriq) combination granted US FDA priority review for first-line maintenance treatment of extensive-stage small cell lung cancer
10 June 2025 - Target action (PDUFA) date set for 7 October 2025. ...
Posted by Michael Wonder on 06 Jun 2025
Arvinas announces submission of new drug application to US FDA for vepdegestrant for patients with ESR1 mutated ER+/HER2- advanced or metastatic breast cancer
6 June 2025 - Arvinas today announced the submission of a new drug application to the US FDA with its partner ...
Posted by Michael Wonder on 06 Jun 2025
Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the first-line setting
6 June 2025 - AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for ...
Posted by Michael Wonder on 04 Jun 2025
Chimeric Therapeutics CDH17 receives FDA fast track
4 June 2025 - Chimeric Therapeutics is pleased to announce that the US FDA has granted CHM CDH17 fast track ...
Posted by Michael Wonder on 04 Jun 2025
Cellectar granted US FDA breakthrough therapy designation for iopofosine I 131 in Waldenstrom macroglobulinemia
4 June 2025 - Designation supported by CLOVER WaM Phase 2 study data which reported an 83.6% overall response rate. ...
Posted by Michael Wonder on 04 Jun 2025
MHRA approves aumolertinib to treat non-small cell lung cancer
3 June 2025 - The MHRA has approved aumolertinib (Aumseqa) for adult patients with non-small cell lung cancer. ...
Posted by Michael Wonder on 03 Jun 2025
Pheast Therapeutics receives FDA fast track designation for PHST001 for the treatment of ovarian cancer
3 June 2025 - Pheast Therapeutics today announced that the US FDA has granted fast track designation to PHST001 for ...
Posted by Michael Wonder on 03 Jun 2025
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with newly diagnosed stage IIb/III/IV Hodgkin lymphoma in combination with ECADD
3 June 2025 - Approval based on positive results from the Phase 3 HD21 trial for stage IIb with risk factors/III/IV ...
Posted by Michael Wonder on 03 Jun 2025
FDA approves darolutamide for metastatic castration-sensitive prostate cancer
3 June 2025 - Today, the FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC). ...
Posted by Michael Wonder on 03 Jun 2025
Ipsen’s Cabometyx kidney cancer reimbursement bid collapses in Korea after price talks fail
30 May 2025 - Ipsen Korea’s months-long effort to expand reimbursement for Cabometyx (cabozantinib) has ended in failure, cutting off ...
Posted by Michael Wonder on 02 Jun 2025
Enhertu (trastuzumab deruxtecan) receives time limited reimbursement recommendation from Canada's Drug Agency for gastric cancer
23 May 2025 - AstraZeneca and Daiichi Sankyo are pleased to announce that Canada's Drug Agency has issued a time-limited reimbursement ...