Blog
RSS FeedPosted by Michael Wonder on 03 Oct 2025
FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer
2 October 2025 - Today, the FDA approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) in combination with atezolizumab (Tecentriq) or atezolizumab and ...
Posted by Michael Wonder on 01 Oct 2025
Enhertu followed by THP supplemental biologics license application accepted in the US for patients with high risk HER2 positive early stage breast cancer prior to surgery
1 October 2025 - Based on results from DESTINY-Breast11, the first Phase 3 trial to demonstrate benefit of Daiichi Sankyo ...
Posted by Michael Wonder on 30 Sep 2025
Umoja Biopharma announces that UB-VV111 receives FDA fast track designation for relapsed/refractory B-cell malignancies
30 September 2025 - Umoja Biopharma announced today that the US FDA has granted fast track designation to UB-VV111 for the ...
Posted by Michael Wonder on 30 Sep 2025
AbbVie submits biologics license application to US FDA for pivekimab sunirine - an investigational antibody-drug conjugate to treat rare cancer with limited treatment options
30 September 2025 - Biologics license application based on data from the global Phase 1/2 CADENZA trial. ...
Posted by Michael Wonder on 30 Sep 2025
FDA approves Guardant360 CDx as companion diagnostic for Eli Lilly and Company’s Inluriyo (imlunestrant) for treatment of ESR1 mutated advanced breast cancer
29 September 2025 - This marks the second FDA approved indication for Guardant360 CDx as a companion diagnostic in breast cancer ...
Posted by Michael Wonder on 25 Sep 2025
Artios receives US FDA fast track designation for alnodesertib in ATM negative metastatic colorectal cancer
24 September 2025 - Artios Pharma today announced that the US FDA granted fast track designation to its ATR inhibitor, ...
Posted by Michael Wonder on 24 Sep 2025
Enhertu plus pertuzumab granted priority review in the US as first-line treatment for patients with HER2 positive metastatic breast cancer
24 September 2025 - Based on DESTINY-Breast09 Phase 3 trial results, which showed Enhertu plus pertuzumab reduced the risk of ...
Posted by Michael Wonder on 19 Sep 2025
FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection
19 September 2025 - Today, the FDA approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult ...
Posted by Michael Wonder on 18 Sep 2025
Minovia Therapeutics receives FDA fast track designation for MNV-201 in myelodysplastic syndrome
18 September 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
Posted by Michael Wonder on 17 Sep 2025
FDA grants fast track designation to Corbus Pharmaceuticals’ nectin-4 targeting ADC CRB-701 in head and neck squamous cell carcinoma
16 September 2025 - Corbus Pharmaceuticals announced today that the US FDA has granted fast track designation to CRB-701 for the ...
Posted by Michael Wonder on 15 Sep 2025
Raludotatug deruxtecan granted breakthrough therapy designation by US FDA for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal or fallopian tube cancers previously treated with bevacizumab
15 September 2025 - Raludotatug deruxtecan has been granted breakthrough therapy designation by the US FDA for the treatment of ...
Posted by Michael Wonder on 11 Sep 2025
FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
10 September 2025 - Corcept Therapeutics today announced that the US FDA has accepted Corcept’s new drug application for relacorilant as ...
Posted by Michael Wonder on 10 Sep 2025
FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
10 September 2025 - Today, the FDA approved selumetinib (Koselugo, AstraZeneca Pharmaceuticals) granules and capsules for paediatric patients 1 year ...
Posted by Michael Wonder on 10 Sep 2025
US FDA approval of Inlexzo (gemcitabine intravesical system) set to transform how certain bladder cancers are treated
9 September 2025 - First and only drug releasing system to provide extended local delivery of a cancer medication into the ...
Posted by Michael Wonder on 09 Sep 2025
FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
9 September 2025 - Today, the FDA approved gemcitabine intravesical system (Inlexzo, Janssen) for adults with Bacillus Calmette-Guérin unresponsive non-muscle ...