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NEWS

Deciphera Pharmaceuticals Reports the CHMP’s Positive Opinion of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots:The CHMP has recommended Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity; EC’s decision is expected in Q3'25Opinion was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without…
July 29, 2025

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Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

Shots:Memo Therapeutics has reported P-II (SAFE KIDNEY II) trial data assessing potravitug vs PBO for the treatment of BK polyomavirus (BKPyV) infection in kidney transplant recipients (n=95)Trial didn’t meet its 1EP of undetectable BKPyV DNAemia but showed superior viral response (≥1-log₁₀ reduction) & resolution of biopsy-proven BKPyVAN by Wk. 20, with histological improvement from…
July 28, 2025

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Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL

Shots:China’s NMPA has granted conditional approval to lisaftoclax for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received ≥1 systemic therapy incl. BTK inhibitorsApproval was based on pivotal P-II (APG2575CC201) trial assessing lisaftoclax monotx. in r/r CLL/SLL pts previously treated with BTK inhibitors &/or immunochemotherapy, which met its 1EP of improved…
July 14, 2025

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HanchorBio Out-Licenses HCB101 to Shanghai Henlius Biotech For ~$202M

Shots:HanchorBio entered into an out-licensing agreement with Shanghai Henlius Biotech and granted exclusive rights to develop and commercialize HCB101 in Greater China, Southeast Asia, and MENAUnder the terms and agreement, HanchorBio will receive $10M upfront and up to $192M in development and regulatory milestones, plus tiered royaltiesHenlius will also oversee development, production,…
July 1, 2025

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Astrazeneca and Daiichi-Sankyo New
NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Shots:The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CTApproval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR…
June 26, 2025

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ExCellThera Reports CHMP’s Positive Opinion for Zemcelpro to Treat Haematological Malignancies

Shots:The CHMP has recommended conditional approval of Zemcelpro in 30 EEA states for adults with haematological malignancies requiring allogeneic HSCT after myeloablative conditioning with no suitable donor; EC’s decision is expected within 2mos.Zemcelpro (UM171 Cell Therapy) was evaluated in P-II trials for pts with high & very high-risk acute leukemias & myelodysplasias with…
June 20, 2025

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Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

Shots:Merck & Daiichi Sankyo have dosed first pts with ifinatamab deruxtecan (I-DXd) in its P-III (IDeate-Prostate01) trial for metastatic castration-resistant prostate cancer (mCRPC), which was initiated based on positive P-I/II (IDeate-PanTumor01) trial dataThe P-III (IDeate-Prostate01) trial will evaluate I-DXd (12mg/kg) vs docetaxel (75mg/m²) plus corticosteroid in ~1440 mCRPC pts, who progressed during or after…
June 19, 2025

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