Blog
RSS FeedPosted by Michael Wonder on 09 May 2026
Lilly's Retevmo moves closer to Korea reimbursement coverage after key review approval
8 May 2026 - Retevmo (selpercatinib), a targeted therapy for RET gene mutation-driven cancers, has cleared a major hurdle toward ...
Posted by Michael Wonder on 08 May 2026
AZ's Imfinzi wins reimbursement for first-line BTC, HCC treatment in Korea
3 March 2026 - AstraZeneca Korea said Tuesday that Imfinzi (durvalumab) is now covered by national health insurance as of ...
Posted by Michael Wonder on 08 May 2026
Nuvation Bio announces FDA acceptance of supplemental new drug application for Ibtrozi (taletrectinib) with updated duration of response in advanced ROS1 positive non-small-cell lung cancer
6 May 2026 - Application includes updated TRUST-I TKI naïve median duration of response and median progression-free survival of more than ...
Posted by Michael Wonder on 08 May 2026
Rznomics announces US FDA regenerative medicine advanced therapy designation granted to RZ-001 for hepatocellular carcinoma
8 May 2026 - RMAT designation based on promising Phase 1b/2a clinical data, including safety profile and preliminary response rates, ...
Posted by Michael Wonder on 07 May 2026
Repertoire Immune Medicines announces FDA fast track designation for its investigational immune medicine, RPTR-1-201
7 May 2026 - Repertoire Immune Medicines today announced that the US FDA has granted fast track designation to RPTR-1-201 for ...
Posted by Michael Wonder on 07 May 2026
Partner Therapeutics announces receipt of FDA Commissioner's National Priority Voucher for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
6 May 2026 - Partner Therapeutics today announced that the US FDA has awarded a Commissioner's National Priority Voucher pilot program ...
Posted by Michael Wonder on 07 May 2026
Diakonos Oncology awarded fast track designation by FDA for DOC1021 (dubodencel) in unresectable or metastatic cutaneous melanoma
6 May 2026 - Diakonos Oncology announced today that the US FDA has granted fast track designation to DOC1021, the ...
Posted by Michael Wonder on 06 May 2026
Guardant Health receives FDA approval for Guardant360 CDx as a companion diagnostic for Arvinas and Pfizer’s Veppanu (vepdegestrant) for patients with ER+/HER2- advanced breast cancer with ESR1 mutations
4 May 2026 - Guardant Health today announced that the US FDA has approved the Guardant360 CDx liquid biopsy test ...
Posted by Michael Wonder on 05 May 2026
Free multiple myeloma therapy now available
5 May 2026 - Eligible Australians with multiple myeloma will now have access to a new free therapy, Carvykti, in ...
Posted by Michael Wonder on 03 May 2026
Affordable treatment for Australians with colorectal cancer
3 May 2026 - Australians with stage 4 colorectal cancer are among those who will benefit from new drug listings ...
Posted by Michael Wonder on 01 May 2026
OS Therapies announces EMA initiates rolling review of conditional marketing authorisation application for OST-HER2 in the prevention or delay of recurrence in fully resected pulmonary metastatic osteosarcoma
30 April 2026 - OS Therapies today announced that the EMA's Committee for Advanced Therapy, in conjunction with the CHMP and ...
Posted by Michael Wonder on 30 Apr 2026
US FDA grants priority review to BeOne Medicines’ Tevimbra in first-line HER2 positive gastro-oesophageal adenocarcinoma
29 April 2026 - BeOne Medicines today announced that the US FDA has granted priority review to a supplemental biologics ...
Posted by Michael Wonder on 30 Apr 2026
Immunome nnounces submission of new drug application to US FDA for varegacestat for the treatment of adults with desmoid tumours
29 April 2026 - Immunome today announced the submission of a new drug application to the US FDA for varegacestat, an ...
Posted by Michael Wonder on 28 Apr 2026
Terns Pharmaceuticals announces FDA breakthrough therapy designation granted to TERN-701 for certain patients with chronic myeloid leukaemia
27 April 2026 - Terns Pharmaceuticals today announced that the US FDA granted breakthrough therapy designation to TERN-701, a novel, oral ...
Posted by Michael Wonder on 28 Apr 2026
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental biologics license application for Ziihera (zanidatamab-hrii) combinations in first-line HER2 positive locally advanced or metastatic gastric cancer
27 April 2026 - Jazz Pharmaceuticals today announced that the US FDA accepted for filing with priority review the supplemental biologics ...