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RSS FeedPosted by Michael Wonder on 09 Jan 2026
858 Therapeutics announces FDA fast track designation for PARG inhibitor ETX-19477 for the treatment of patients with BRCA mutated, platinum resistant ovarian cancer
8 January 2026 - 858 Therapeutics today announced that the US FDA has granted fast track designation to ETX-19477, the company’s ...
Posted by Michael Wonder on 09 Jan 2026
Alessa Therapeutics announces FDA fast track designation for Enolen, a first of its kind treatment for localised prostate cancer
8 January 2026 - Alessa Therapeutics today announced that the US FDA has granted fast track designation for Enolen, the ...
Posted by Michael Wonder on 07 Jan 2026
Johnson & Johnson submits application to the EMA for Tecvayli (teclistamab) in combination with Darzalex (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma
5 January 2026 - The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement ...
Posted by Michael Wonder on 06 Jan 2026
Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer
6 January 2026 - Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for ...
Posted by Michael Wonder on 05 Jan 2026
Protara Therapeutics receives both FDA breakthrough therapy and fast track designations for TARA-002 in paediatric patients with lymphatic malformations
5 January 2026 - Protara Therapeutics today announced that the US FDA has granted both breakthrough therapy and fast track designations ...
Posted by Michael Wonder on 03 Jan 2026
Family’s desperate plea as lifesaving cancer drug delayed by PBS bureaucracy
3 January 2026 - A $32,000 cancer treatment has given one man hope of seeing his children grow up, but PBS ...
Posted by Michael Wonder on 25 Dec 2025
Korea to expand Keytruda reimbursement to 11 new cancer uses starting 2026
24 December 2025 - Korea’s national health insurance program will broaden reimbursement for MSD’s blockbuster PD-1 inhibitor Keytruda in a ...
Posted by Michael Wonder on 25 Dec 2025
Health Canada approves Tevimbra (tislelizumab for injection) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma
23 December 2025 - Approval supported by results of the RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival ...
Posted by Michael Wonder on 24 Dec 2025
Thousands more people with advanced bowel cancer to benefit as NICE approves bevacizumab biosimilars
24 December 2025 - More than 7,000 people in England will now be able to access to a life-extending treatment for ...
Posted by Michael Wonder on 24 Dec 2025
Lilly’s Jaypirca wins Korea reimbursement for relapsed mantle cell lymphoma
10 October 2025 - Eli Lilly’s Jaypirca (pirtobrutinib) has been added to Korea’s national health insurance effective Oct. 1 for ...
Posted by Michael Wonder on 22 Dec 2025
FDA approves Roche’s Lunsumio Velo for subcutaneous use in relapsed or refractory follicular lymphoma
22 December 2025 - Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which ...
Posted by Michael Wonder on 22 Dec 2025
Enhertu granted breakthrough therapy designation in the US as post-neo-adjuvant therapy for patients with HER2 positive early breast cancer
22 December 2025 - Tenth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast05 ...
Posted by Michael Wonder on 20 Dec 2025
Alphamab Oncology announces biparatopic HER2 targeting ADC JSKN003 was granted breakthrough therapy designation by the FDA for the treatment of PROC
20 December 2025 - Alphamab Oncology announced that the biparatopic HER2 targeting antibody drug conjugate JSKN003, independently by the US FDA ...
Posted by Michael Wonder on 19 Dec 2025
BeOne Medicines granted US FDA fast track designation for BGB-B2033 as treatment for hepatocellular carcinoma
18 December 2025 - BGB-B2033 is a bispecific antibody directed at GPC3 and 4-1BB; key targets in the most common liver ...
Posted by Michael Wonder on 18 Dec 2025
FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection
17 December 2025 - Today, the FDA approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech) for subcutaneous injection for adult ...