Blog
RSS FeedPosted by Michael Wonder on 01 May 2025
MHRA authorises cancer treatment variation with an administration time of 3–5 minutes
30 April 2025 - The MHRA has today approved a new under-the-skin injection version of the cancer therapy, nivolumab (Opdivo), ...
Posted by Michael Wonder on 30 Apr 2025
Roche granted FDA breakthrough device designation for first AI-driven companion diagnostic for non-small cell lung cancer
29 April 2025 - The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to ...
Posted by Michael Wonder on 29 Apr 2025
BioInvent receives FDA fast track designation for BI-1808 for the treatment of cutaneous T-cell lymphoma
29 April 2025 - BioInvent today announces that the US FDA has granted fast track designation to BI-1808, a first-in-class ...
Posted by Michael Wonder on 29 Apr 2025
Incyclix Bio granted US FDA fast track designation for INX-315 to treat CCNE1-amplified platinum-resistant/refractory ovarian cancer
29 April 2025 - Incyclix Bio today announced that the US FDA has granted fast track designation for INX-315 for ...
Posted by Michael Wonder on 29 Apr 2025
Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for first-line chronic lymphocytic leukaemia
29 April 2025 - Recommendation based on AMPLIFY Phase III trial which showed Calquence combinations demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 28 Apr 2025
Come to grips’: fighting lymphoma from home
28 April 2025 - Australian patients with the most common form of lymphoma will for the first time have access ...
Posted by Michael Wonder on 25 Apr 2025
Multiple myeloma drug subsidised after treatment costs ballooned
24 April 2025 - It’s one of the few cancers still considered incurable, and those diagnosed with multiple myeloma will likely ...
Posted by Michael Wonder on 25 Apr 2025
FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma
23 April 2025 - Today, the FDA approved penpulimab-kcqx (Akeso Biopharma) with cisplatin or carboplatin and gemcitabine for the first-line ...
Posted by Michael Wonder on 24 Apr 2025
Sarclisa approved in Canada for patients with newly diagnosed multiple myeloma
22 April 2025 - This is the third indication for Sarclisa in Canada for the treatment of multiple myeloma. ...
Posted by Michael Wonder on 23 Apr 2025
Health Canada approves Keytruda plus pemetrexed and platinum chemotherapy as first-line treatment for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma
22 April 2025 - Approval is based on the results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial. ...
Posted by Michael Wonder on 22 Apr 2025
FDA grants breakthrough therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours
22 April 2025 - Breakthrough therapy designation is based on the encouraging survival data from the Phase 1 BrainChild-03 trial in ...
Posted by Michael Wonder on 18 Apr 2025
Health Canada expands Jemperli (dostarlimab for injection) plus chemotherapy approval to all adult patients with primary advanced or first recurrent endometrial cancer, as the first and only immuno-oncology-based treatment to show an overall survival benefit for these patients
17 April 2025 - Approval based on RUBY Part 1 trial, where Jemperli plus chemotherapy demonstrated a statistically significant and ...
Posted by Michael Wonder on 16 Apr 2025
Merck’s Tepmetko wins reimbursement in Korea after 3.5 years, expanding access for lung cancer patients with rare MET mutation
15 April 2025 - Merck’s targeted lung cancer therapy Tepmetko (tepotinib) has finally secured reimbursement from the National Health Insurance ...
Posted by Michael Wonder on 14 Apr 2025
SynOx Therapeutics receives fast track designation from US FDA for emactuzumab for tenosynovial giant cell tumours
14 April 2025 - SynOx Therapeutics today announced that the US FDA has granted fast track designation to emactuzumab for the ...
Posted by Michael Wonder on 14 Apr 2025
European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy
14 April 2025 - Approval based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction ...