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RSS FeedPosted by Michael Wonder on 19 Jan 2025
Junshi Biosciences announces toripalimab’s approval in Australia
17 January 2025 - Shanghai Junshi Biosciences announced that toripalimab, the anti-PD-1 monoclonal antibody self-developed by the company, has obtained the ...
Posted by Michael Wonder on 19 Jan 2025
Long wait for cancer drug approvals causing 'great anguish' among patients, doctors
18 January 2025 - Potentially life-saving treatments delayed by bureaucracy, doctors say. ...
Posted by Michael Wonder on 19 Jan 2025
US FDA approves FoundationOne CDx as a companion diagnostic for Ojemda (tovorafenib) to treat the most common form of childhood brain tumour in paediatric patients
17 January 2025 - The approval supports the identification of therapeutic options for patients with relapsed or refractory BRAF altered paediatric ...
Posted by Michael Wonder on 17 Jan 2025
Senaparib approved by NMPA for first-line maintenance therapy in ovarian cancer
16 January 2025 - Impact Therapeutics is pleased to announce that senaparib capsules has received marketing authorisation in China from ...
Posted by Michael Wonder on 17 Jan 2025
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR positive, HER2 negative breast cancer
17 January 2025 - Today, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, ...
Posted by Michael Wonder on 17 Jan 2025
Rybrevant plus chemotherapy approved in Canada as first and only targeted treatment to reduce risk of disease progression or death by more than half in second-line EGFR mutated advanced lung cancer
16 January 2025 - Phase 3 MARIPOSA-2 study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival compared ...
Posted by Michael Wonder on 17 Jan 2025
Innovent receives NMPA breakthrough therapy designation for IBI343 (anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer
16 January 2025 - Innovent Biologics announced that the Center for Drug Evaluation of China's National Medical Products Administration has granted ...
Posted by Michael Wonder on 16 Jan 2025
FDA approves sotorasib with panitumumab for KRAS G12C mutated colorectal cancer
16 January 2025 - Today, the FDA approved sotorasib (Lumakras, Amgen) with panitumumab (Vectibix, Amgen) for adult patients with KRAS ...
Posted by Michael Wonder on 16 Jan 2025
Foresee Pharmaceuticals announces the PDUFA goal date for the 3 month version of Camcevi is 29 August 2025
13 January 2025 - Foresee Pharmaceuticals announces that the US FDA issued a Day 74 letter. ...
Posted by Michael Wonder on 16 Jan 2025
FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma
16 January 2025 - Today, the FDA granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults ...
Posted by Michael Wonder on 16 Jan 2025
ImmunityBio provides regulatory update on global submission for Anktiva + BCG in BCG unresponsive non-muscle invasive bladder cancer with carcinoma in situ in Europe and United Kingdom
15 January 2025 - ImmunityBio responding to requests for information from both Agencies and the potential for approval in European Union ...
Posted by Michael Wonder on 16 Jan 2025
PHARMAC consulting on widening access to venetoclax, azacitidine and upadacitinib monohydrate
16 January 2025 - PHARMAC is asking for feedback on a proposal to widen access to three medicines for five ...
Posted by Michael Wonder on 15 Jan 2025
New drug application initiated with US FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
15 January 2025 - Application accepted for US FDA Real-Time Oncology Review based on Phase 2b SunRISe-1 study showing highest ...
Posted by Michael Wonder on 15 Jan 2025
Capivasertib in combination with fulvestrant for the treatment of patients with advanced, hormone receptor positive, HER2 negative breast cancer after endocrine treatment
14 January 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 14 Jan 2025
Lokon Pharma receives FDA fast track designation for LOAd703 for the treatment of pancreatic cancer
10 January 2025 - Lokon Pharma today announced that the US FDA has granted fast track designation for the company´s product ...