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RSS FeedPosted by Michael Wonder on 03 Jun 2025
FDA approves darolutamide for metastatic castration-sensitive prostate cancer
3 June 2025 - Today, the FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC). ...
Posted by Michael Wonder on 02 Jun 2025
Kura Oncology and Kyowa Kirin announce FDA acceptance and priority review of new drug application for ziftomenib in adults with relapsed or refractory NPM1 mutant AML
1 June 2025 - New drug application based on positive results from the Phase 2 KOMET-001 trial. ...
Posted by Michael Wonder on 29 May 2025
Patritumab deruxtecan biologics license application for patients with previously treated locally advanced or metastatic EGFR mutated non-small cell lung cancer voluntarily withdrawn
29 May 2025 - The biologics license application seeking accelerated approval in the US for Daiichi Sankyo and Merck's patritumab ...
Posted by Michael Wonder on 28 May 2025
Experimental Drug Development Centre granted US FDA fast track designation for antibody-drug conjugate EBC-129 to treat pancreatic ductal adenocarcinoma
28 May 2025 - EBC-129 is the first made in Singapore antibody-drug conjugate to enter clinical development. ...
Posted by Michael Wonder on 28 May 2025
Candel Therapeutics receives FDA regenerative medicine advanced therapy designation for CAN-2409 for the treatment of prostate cancer
28 May 2025 - Candel Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to CAN-2409 ...
Posted by Michael Wonder on 28 May 2025
US FDA accepts new drug application under priority review for sevabertinib (BAY 2927088) in HER2 mutant non-small cell lung cancer
28 May 2025 - Regulatory submission is based on positive results from the on-going Phase I/II SOHO-01 trial in patients with ...
Posted by Michael Wonder on 19 May 2025
Zai Lab receives US FDA fast track designation for ZL-1310, a DLL3 targeted antibody drug conjugate, for treatment of extensive stage small cell lung cancer
19 May 2025 - The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung ...
Posted by Michael Wonder on 16 May 2025
FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal
15 May 2025 - Today, the FDA approved retifanlimab-dlwr (Zynyz, Incyte) with carboplatin and paclitaxel for the first-line treatment of ...
Posted by Michael Wonder on 14 May 2025
FDA grants accelerated approval to telisotuzumab vedotin-tllv for non-small cell lung cancer with high c-Met protein overexpression
14 May 2025 - Today, the FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie), a c-Met-directed antibody and microtubule ...
Posted by Michael Wonder on 08 May 2025
FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer
8 May 2025 - Today, the FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, ...
Posted by Michael Wonder on 07 May 2025
Adcentrx Therapeutics granted fast track designation for ADRX-0706 nectin-4 antibody drug conjugate for the treatment of advanced cervical cancer
6 May 2025 - Adcentrx Therapeutics today announced that the US FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 07 May 2025
ImmunityBio requests an urgent meeting with FDA to address the change in the Agency’s unambiguous guidance on Jan 2025 to submit a sBLA for NMIBC BCG unresponsive papillary disease, following an inconsistent refusal to file letter on 2 May 2025
5 May 2025 - ImmunityBio today announced that the Company received a refusal to file letter from the US FDA for ...
Posted by Michael Wonder on 06 May 2025
Ichnos Glenmark Innovation receives US FDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma
5 May 2025 - IGI, today announced that the US FDA has granted fast track designation for ISB 2001. ...
Posted by Michael Wonder on 30 Apr 2025
Roche granted FDA breakthrough device designation for first AI-driven companion diagnostic for non-small cell lung cancer
29 April 2025 - The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to ...
Posted by Michael Wonder on 29 Apr 2025
BioInvent receives FDA fast track designation for BI-1808 for the treatment of cutaneous T-cell lymphoma
29 April 2025 - BioInvent today announces that the US FDA has granted fast track designation to BI-1808, a first-in-class ...