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RSS FeedPosted by Michael Wonder on 12 Dec 2024
Elranatamab for treating relapsed and refractory multiple myeloma after three or more treatments (final guidance)
11 December 2024 - NICE has published final evidence-based recommendations on the use of elranatamab (Elrexfio) for the treatment of ...
Posted by Michael Wonder on 10 Dec 2024
Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
9 December 2024 - First breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan based on TROPION-Lung05 Phase 2 ...
Posted by Michael Wonder on 08 Dec 2024
Autopsy of a drug withdrawal — the case of melphalan flufenamide
7 December 2024 - The accelerated approval pathway, which was established in 1992, has expedited approvals of drugs for serious and ...
Posted by Michael Wonder on 07 Dec 2024
FDA accepts supplemental biologics license application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
5 December 2024 - Application is based on data from the Phase 3 STARGLO study where Columvi plus chemotherapy showed a ...
Posted by Michael Wonder on 07 Dec 2024
FDA approves durvalumab for limited-stage small cell lung cancer
4 December 2024 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer whose ...
Posted by Michael Wonder on 07 Dec 2024
FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma
4 December 2024 - This represents the first FDA approval of a systemic therapy for patients with non-small cell lung cancer ...
Posted by Michael Wonder on 07 Dec 2024
Lantern Pharma's investigational drug candidate, LP-184, receives second fast track designation from FDA for treatment of triple negative breast cancer
3 December 2024 - LP-184 has demonstrated significant pre-clinical efficacy in triple negative breast cancer models, including those resistant to PARP ...
Posted by Michael Wonder on 07 Dec 2024
FDA grants fast track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer
3 December 2024 - Corbus Pharmaceuticals announced today that the US FDA has granted fast track designation to CRB-701 for the ...
Posted by Michael Wonder on 06 Dec 2024
Rigel announces R289 granted fast track designation by the FDA for lower risk myelodysplastic syndrome
2 December 2024 - Rigel Pharmaceuticals today announced that the US FDA has granted fast track designation to R289 for the ...
Posted by Michael Wonder on 06 Dec 2024
FDA grants breakthrough therapy designation to sacituzumab tirumotecan for the treatment of certain patients with previously treated advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations
3 December 2024 - First breakthrough therapy designation for investigational sac-TMT in the US. ...
Posted by Michael Wonder on 05 Dec 2024
PHARMAC funds more cancer and respiratory medicines for New Zealanders
6 December 2024 - More publicly funded medicines are on the way for people with types of breast and lung ...
Posted by Michael Wonder on 05 Dec 2024
Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan approved for marketing by NMPA of China for second-line advanced or metastatic triple negative breast cancer
27 November 2024 - Sichuan Kelun-Biotech Biopharmaceutical announced that the Company received marketing authorisation in China from the NMPA for the ...
Posted by Michael Wonder on 05 Dec 2024
Lin BioScience receives US FDA fast track designation for LBS-007
27 November 2024 - A Phase 1/2 trial in patients with relapsed or resistant acute leukaemias is on-going. ...
Posted by Michael Wonder on 05 Dec 2024
Exelixis provides regulatory update related to supplemental new drug application for cabozantinib (Cabometyx) for the treatment of patients with previously treated advanced neuroendocrine tumors
26 November 2024 - 26, 2024-- Exelixis today announced that the US FDA has notified the company that the supplemental new ...
Posted by Michael Wonder on 05 Dec 2024
European Commission approves BeiGene’s Tevimbra for first-line treatment of advanced/metastatic oesophageal squamous cell carcinoma and gastric or gastro-oesophageal junction cancer
27 November 2024 - New indications based on two Phase 3 studies demonstrating statistically significant overall survival benefit for patients ...