Blog
RSS FeedPosted by Michael Wonder on 27 Dec 2024
FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
27 December 2024 - Today, the FDA approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous injection across ...
Posted by Michael Wonder on 24 Dec 2024
Datopotamab deruxtecan application in the EU for patients with advanced non-squamous non-small sell lung cancer voluntarily withdrawn
24 December 2024 - Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorisation application in the EU for datopotamab ...
Posted by Michael Wonder on 24 Dec 2024
US FDA accepts for priority review Nuvation Bio’s new drug application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer
23 December 2024 - New drug application is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies ...
Posted by Michael Wonder on 23 Dec 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer
23 December 2024 - Approval based on results of the Phase 3 CheckMate-8HW trial, in which the dual immunotherapy combination ...
Posted by Michael Wonder on 23 Dec 2024
Tagrisso approved in the EU for patients with unresectable EGFR mutated lung cancer
23 December 2024 - Approval based on LAURA Phase 3 trial results which showed Tagrisso extended median progression-free survival to ...
Posted by Michael Wonder on 22 Dec 2024
Nurix Therapeutics receives US FDA fast track designation for NX-5948 for the treatment of relapsed or refractory Waldenstrom’s macroglobulinaemia
19 December 2024 - Fast track designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenstrom’s macroglobulinaemia. ...
Posted by Michael Wonder on 20 Dec 2024
FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation
20 December 2024 - Today, the FDA granted accelerated approval to encorafenib (Braftovi, Array BioPharma) with cetuximab and mFOLFOX6 for ...
Posted by Michael Wonder on 18 Dec 2024
Johnson & Johnson submits application to the EMA seeking approval of a new indication for Imbruvica (ibrutinib) in adult patients with previously untreated mantle cell lymphoma who are eligible for autologous stem cell transplant
18 December 2024 - The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with ...
Posted by Michael Wonder on 18 Dec 2024
FDA approves ensartinib for ALK positive locally advanced or metastatic non-small cell lung cancer
18 December 2024 - Today, the FDA approved ensartinib (Ensacove, Xcovery) for adult patients with anaplastic lymphoma kinase (ALK) positive ...
Posted by Michael Wonder on 18 Dec 2024
GSK’s B7-H3 targeted antibody drug conjugate, GSK’227, receives EMA Priority Medicines (PRIME) designation in relapsed extensive-stage small-cell lung cancer
16 December 2024 - Regulatory designation based on promising preliminary clinical data. ...
Posted by Michael Wonder on 17 Dec 2024
US FDA grants breakthrough therapy designation to Trodelvy (sacituzumab govitecan-hziy) for second-line treatment of extensive-stage small cell lung cancer
17 December 2024 - Gilead Sciences today announced that the US FDA has granted breakthrough therapy designation to Trodelvy (sacituzumab ...
Posted by Michael Wonder on 17 Dec 2024
Update on US regulatory review of subcutaneous amivantamab
16 December 2024 - Johnson & Johnson today announced the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 14 Dec 2024
First medicine to treat rare genetic disorder causing cysts and tumours
13 December 2024 - Oral medicine to treat two different conditions, rare von Hippel-Lindau disease and advanced clear cell renal cell ...
Posted by Michael Wonder on 13 Dec 2024
FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
13 December 2024 - Today, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, for ...
Posted by Michael Wonder on 13 Dec 2024
Phanes Therapeutics’ PT217 granted fast track designation by the FDA for NEPC
4 December 2024 - This is the second fast track designation granted to PT217 by the agency ...