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RSS FeedPosted by Michael Wonder on 24 Feb 2025
US FDA grants fast track designation to Coherent Biopharma’s CBP-1019
21 February 2025 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1019 for the treatment ...
Posted by Michael Wonder on 24 Feb 2025
Auron Therapeutics announces AUTX-703 granted fast track designation by the FDA for relapsed or refractory acute myelogenous leukaemia
24 February 2025 - Auron Therapeutics today announced that the US FDA has granted fast track designation to AUTX-703 for ...
Posted by Michael Wonder on 24 Feb 2025
US FDA accepts BMS’s supplemental biologics license application for Opdivo plus Yervoy for patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
24 February 2025 - Application based on analyses from the Phase 3 CheckMate-8HW clinical trial, in which Opdivo plus Yervoy demonstrated ...
Posted by Michael Wonder on 23 Feb 2025
HIRA to remove 17 medicines from group 2 anti-cancer list, update reimbursement criteria
21 February 2025 - Korea's HIRA said it has decided to remove 17 medicines from the list of group 2 ...
Posted by Michael Wonder on 22 Feb 2025
Health Canada authorizes Itovebi (inavolisib film-coated tablets), a targeted treatment for advanced hormone receptor-positive, HER2 negative breast cancer with a PIK3CA mutation
19 February 2025 - The approval provides another treatment option for breast cancer patients with a PIK3CA mutation, one of the ...
Posted by Michael Wonder on 21 Feb 2025
Green light for groundbreaking personalised cancer therapy that reprogrammes immune system
20 February 2025 - Final guidance published today recommends lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) as an option for treating ...
Posted by Michael Wonder on 21 Feb 2025
Use of surrogate endpoints in health technology assessment: a review of selected NICE technology appraisals in oncology
19 February 2025 - Surrogate endpoints, used to substitute for and predict final clinical outcomes, are increasingly being used to support ...
Posted by Michael Wonder on 21 Feb 2025
Epkinly (epcoritamab) approved by Japan Ministry of Health, Labour and Welfare for additional indication as a treatment for relapsed or refractory follicular lymphoma
20 February 2025 - Approval based on results from two Phase 1/2 EPCORE clinical trials, which demonstrated strong and durable efficacy ...
Posted by Michael Wonder on 20 Feb 2025
World’s first potential target therapy for diffuse gastric cancer granted fast track designation by the US FDA
20 February 2025 - Signet Therapeutics announced that the US FDA has granted fast track designation for SIGX1094, the world's first ...
Posted by Michael Wonder on 20 Feb 2025
Boehringer’s zongertinib receives priority review from US FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer
19 February 2025 - The application for this investigational treatment is based on positive results from the Phase Ib Beamion LUNG-1, ...
Posted by Michael Wonder on 20 Feb 2025
Clarity receives US FDA fast track designation for the treatment of metastatic castration resistant prostate cancer patients with copper Cu 67 SAR-bisPSMA
19 February 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 19 Feb 2025
Selpercatinib for the treatment of patients with advanced RET fusion positive non-small-cell lung cancer
19 February 2025 - NICE has published final evidence-based recommendations on the use of selpercatinib (Retsevmo) for the treatment of ...
Posted by Michael Wonder on 19 Feb 2025
Durvalumab in combination with etoposide phosphate and either carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small-cell lung cancer
19 February 2025 - NICE has published final evidence-based recommendations on the use of durvalumab (Imfinzi) in combination with etoposide ...
Posted by Michael Wonder on 18 Feb 2025
Petosemtamab granted breakthrough therapy designation by the US FDA for first-line PD-L1 positive head and neck squamous cell carcinoma
18 February 2025 - This marks the second breakthrough therapy designation for petosemtamab in head and neck squamous cell carcinoma. ...
Posted by Michael Wonder on 17 Feb 2025
Innovent receives second fast track designation from the US FDA for IBI363 (PD-1/IL-2α-bias bipspecific antibody fusion protein) in squamous non-small cell lung cancer
17 February 2025 - Innovent Biologics announced that its first in class PD-1/IL-2α-bias bi-specific antibody fusion protein, IBI363, has received its ...