Blog
RSS FeedPosted by Michael Wonder on 05 Jun 2026
US FDA approves FoundationOne CDx as a companion diagnostic for Itovebi (inavolisib) to identify patients with hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
2 June 2026 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx ...
Posted by Michael Wonder on 03 Jun 2026
Cingulate receives complete response letter from FDA for CTx-1301
2 June 2026 - Cingulate today announced that the US FDA has issued a complete response letter for its new ...
Posted by Michael Wonder on 03 Jun 2026
Agilent receives FDA approval for expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis in oesophageal squamous cell carcinoma, triple negative breast cancer, cervical cancer and gastric or gastro-oesophageal junction adenocarcinoma
2 June 2026 - Approval expands PD-L1 testing onto an automated workflow to support treatment decisions with Keytruda (pembrolizumab). ...
Posted by Michael Wonder on 01 Jun 2026
Shionogi announces FDA approval of Xocova (ensitrelvir), the first and only oral option to help prevent COVID-19 following exposure
1 June 2026 - Approval is based on SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet the ...
Posted by Michael Wonder on 31 May 2026
MannKind announces FDA approval of Afrezza, the first and only inhaled mealtime insulin for use in children and adolescents aged 6 and older living with diabetes
29 May 2026 - Eligible patients can access Afrezza today for $35 or less per month, with dedicated support through MannKind ...
Posted by Michael Wonder on 29 May 2026
FDA approves label expansion, cementing Tremfya as the only IL‑23 inhibitor proven to help stop further joint damage
28 May 2026 - Johnson & Johnson announced today that the US FDA has approved a supplemental biologics license application to ...
Posted by Michael Wonder on 29 May 2026
Imfinzi approved in the US in first and only immunotherapy combination for patients with BCG naïve, high risk non-muscle-invasive bladder cancer
28 May 2026 - Based on POTOMAC Phase 3 trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 28 May 2026
FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer
28 May 2026 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment ...
Posted by Michael Wonder on 28 May 2026
US FDA approves Decnupaz (pivekimab sunirine-pvzy) for treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm, an ultra rare and aggressive blood cancer with limited treatment options
27 May 2026 - AbbVie today announced that the US FDA has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of ...
Posted by Michael Wonder on 27 May 2026
FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy
27 May 2026 - Today, the FDA approved pivekimab sunirine-pvzy (Decnupaz, AbbVie), a CD123-directed antibody and alkylating agent conjugate, for ...
Posted by Michael Wonder on 24 May 2026
FDA grants accelerated approval to Gilead’s Hepcludex (bulevirtide-gmod), the first and only approved treatment for chronic hepatitis delta virus
22 May 2026 - Approval introduces the first FDA approved therapy for this disease with limited treatment options and high ...
Posted by Michael Wonder on 22 May 2026
Datroway approved in the US as first TROP2 directed antibody drug conjugate for first-line treatment of patients with metastatic triple negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
22 May 2026 - Daiichi Sankyo and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment ...
Posted by Michael Wonder on 22 May 2026
Datroway approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
22 May 2026 - AstraZeneca and Daiichi Sankyo’s Datroway is the only TROP2-directed antibody drug conjugate to prolong overall survival in ...
Posted by Michael Wonder on 22 May 2026
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple negative breast cancer
22 May 2026 - Today, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adult patients with unresectable or metastatic ...
Posted by Michael Wonder on 22 May 2026
FDA approves first treatment for chronic hepatitis delta virus infection
22 May 2026 - Today, the US FDA approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus infection in adults ...