Blog
RSS FeedPosted by Michael Wonder on 05 Jun 2024
Nivolumab for the adjuvant treatment of patients 12 years and older with completely resected melanoma at high risk of recurrence
5 June 2024 - NICE is unable to make a recommendation on the use of nivolumab (Opdivo) for the adjuvant treatment ...
Posted by Michael Wonder on 04 Jun 2024
CStone announces European Medicine Agency CHMP recommends approval of Cejemly (sugemalimab, anti-PD-L1) as first-line treatment for NSCLC
1 June 2024 - EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant ...
Posted by Michael Wonder on 04 Jun 2024
Repare Therapeutics announces fast track designation granted by the FDA for lunresertib in combination with camonsertib for the treatment of platinum resistant ovarian cancer
4 June 2024 - Repare Therapeutics today announced the US FDA has granted fast track designation to lunresertib in combination with ...
Posted by Michael Wonder on 03 Jun 2024
Paediatric rare disease drug Qarziba gets green light for coverage
30 May 2024 - The Health Insurance Review and Assessment Service (HIRA) held its fourth Cancer Disease Review Committee (CDRC) ...
Posted by Michael Wonder on 03 Jun 2024
Tagrisso with the addition of chemotherapy recommended for approval in the EU by CHMP for patients with EGFR mutated advanced lung cancer
3 June 2024 - Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 03 Jun 2024
Johnson & Johnson submits application to the EMA seeking approval of subcutaneous formulation of Rybrevant (amivantamab) for the treatment of patients with EGFR mutated non-small cell lung cancer
31 May 2024 - Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of ...
Posted by Michael Wonder on 03 Jun 2024
Project Orbis: quicker access to promising cancer treatments
29 May 2024 - Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs. ...
Posted by Michael Wonder on 03 Jun 2024
Zanidatamab granted priority review for HER2 positive metastatic biliary tract cancer
29 May 2024 - Target action (PDUFA) date set for 29 November 2024. ...
Posted by Michael Wonder on 02 Jun 2024
US FDA acknowledges Astellas' resubmission of biologics license application for zolbetuximab and sets new action date
30 May 2024 - If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and ...
Posted by Michael Wonder on 01 Jun 2024
Cancer is capsizing Americans’ finances. ‘I was losing everything.’
28 May 2024 - Higher drug prices, rising out of pocket costs and reduced incomes create economic strain for many patients. ...
Posted by Michael Wonder on 31 May 2024
NH TherAguix receives FDA fast track designation for AGuIX, its novel radio-enhancer in the treatment of malignant gliomas, and provides an update on its developments and prospects
30 May 2024 - Key regulatory milestone confirming the interest of the US authorities in AGuIX, a next generation nanodrug ...
Posted by Michael Wonder on 30 May 2024
US FDA approves Bristol Myers Squibb’s Breyanzi as a new CAR T-cell therapy for relapsed or refractory mantle cell lymphoma
30 May 2024 - In the MCL cohort of TRANSCEND-NHL-001, Breyanzi delivered responses in 85.3% of patients with a one-time infusion ...
Posted by Michael Wonder on 30 May 2024
Budget 2024 health: no funding for promised cancer drugs disappoints breast cancer patient - extension to screening welcomed
30 May 2024 - A cancer patient is disappointed with a lack of funding for new medicines in Budget 2024, ...
Posted by Michael Wonder on 30 May 2024
Affimed receives fast track designation for combination therapy of AFM24 with atezolizumab for EGFR wild type non-small cell lung cancer
29 May 2024 - The FDA’s fast track designation was granted after its review of the initial efficacy data of the ...
Posted by Michael Wonder on 30 May 2024
FDA grants priority review to Roche’s inavolisib for advanced hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
29 May 2024 - The target action date for the FDA decision is 27 November 2024. ...