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RSS FeedPosted 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 12 May 2025
Erdafitinib for the treatment of patients with unresectable or metastatic urothelial cancer with an FGFR3 alteration after a PD-1 or PD-L1 inhibitor
12 May 2025 - Erdafitinib is recommended as an option for the treatment of adults with unresectable or metastatic urothelial cancer ...
Posted by Michael Wonder on 09 May 2025
Adagrasib for previously treated patients with advanced KRAS G12C mutation positive non-small-cell lung cancer
9 May 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 09 May 2025
Osimertinib mesylate in combination with pemetrexed disodium heptahydrate and platinum-based chemotherapy for patients with advanced EGFR mutation positive non-small-cell lung cancer (final guidance)
8 May 2025 - Osimertinib mesylate, when used in combination with pemetrexed disodium heptahydrate and platinum-based chemotherapy, is recommended as an ...
Posted by Michael Wonder on 08 May 2025
PHARMAC funds and widens access to melanoma medicines
9 May 2025 - PHARMAC is funding more medicines for people with skin cancer (melanoma), from 1 June 2025. ...
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
Calquence plus chemoimmunotherapy approved in the EU as first and only BTK inhibitor for first-line mantle cell lymphoma
6 May 2025 - Approval based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival ...
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 02 May 2025
Pfizer’s ALK lung cancer drug Lorviqua lands first-line reimbursement in Korea
2 May 2025 - Pfizer Korea has secured reimbursement for Lorviqua (lorlatinib) as a first-line treatment for ALK-positive metastatic non-small ...
Posted by Michael Wonder on 01 May 2025
MHRA authorises cancer treatment variation with an administration time of 3–5 minutes
30 April 2025 - The MHRA has today approved a new under-the-skin injection version of the cancer therapy, nivolumab (Opdivo), ...
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 ...
Posted by Michael Wonder on 29 Apr 2025
Incyclix Bio granted US FDA fast track designation for INX-315 to treat CCNE1-amplified platinum-resistant/refractory ovarian cancer
29 April 2025 - Incyclix Bio today announced that the US FDA has granted fast track designation for INX-315 for ...