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RSS FeedPosted by Michael Wonder on 11 Jul 2026
Elevar Therapeutics receives FDA complete response letter for combination of rivoceranib and camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma
10 July 2026 - Elevar Therapeutics today announced that the US FDA issued a complete response lette regarding its new ...
Posted by Michael Wonder on 11 Jul 2026
FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
10 July 2026 - Today, the FDA approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each ...
Posted by Michael Wonder on 11 Jul 2026
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
10 July 2026 - On 9 July 2026, the FDA approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis) for subcutaneous injection for multiple myeloma ...
Posted by Michael Wonder on 09 Jul 2026
Terremoto Biosciences granted FDA fast track designation for TER-2013, an AKT1 selective small molecule inhibitor for breast cancer
3 July 2026 - Terremoto Biosciences today announced that the US FDA granted fast track designation for TER-2013, the Company’s lead ...
Posted by Michael Wonder on 09 Jul 2026
Immunome announces US FDA acceptance of new drug application for varegacestat for the treatment of adults with desmoid tumors
8 July 2026 - Immunome today announced the US FDA has accepted its new drug application for varegacestat, an investigational, ...
Posted by Michael Wonder on 03 Jul 2026
FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies
30 June 2026 - Today, the FDA approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell and ...
Posted by Michael Wonder on 28 Jun 2026
Replimune announces FDA acceptance of RP1 biologics license application resubmission for advanced melanoma
26 June 2026 - FDA decision expected by 2 August 2026. ...
Posted by Michael Wonder on 26 Jun 2026
FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer
24 June 2026 - Today, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) for two indications in adults with triple ...
Posted by Michael Wonder on 23 Jun 2026
Regulators often diverge from FDA on expedited oncology approvals
22 June 2026 - Among oncology drugs first approved by the US FDA, other regulatory authorities varied in how they ...
Posted by Michael Wonder on 19 Jun 2026
FDA accepts supplemental biologics license application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphoma
18 June 2026 - Roche announced today that the US FDA has accepted the company’s supplemental biologics license application for Lunsumio ...
Posted by Michael Wonder on 17 Jun 2026
NovaBridge Biosciences receives FDA fast track designation for givastomig in first-line HER2 negative metastatic gastric cancer
16 June 2026 - NovaBridge Biosciences today announced that the US FDA has granted fast track designation to givastomig in combination ...
Posted by Michael Wonder on 16 Jun 2026
Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer
12 June 2026 - Roche announced today that the Ventana PTEN (SP218) RxDx Assay is the first immunohistochemistry companion diagnostic test ...
Posted by Michael Wonder on 13 Jun 2026
Guardant Health announces FDA approval of Guardant360 CDx as companion diagnostic for Boehringer Ingelheim’s Hernexeos
11 June 2026 - Guardant Health today announced that the US FDA has approved Guardant360 CDx as a companion diagnostic ...
Posted by Michael Wonder on 12 Jun 2026
FDA grants priority review for Genentech’s Tecentriq for a certain type of stage III colon cancer
10 June 2026 - Genentech announced today that the US FDA has accepted the company’s supplemental biologics license application filing for ...
Posted by Michael Wonder on 12 Jun 2026
FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
12 June 2026 - Today, the FDA approved belzutifan (Welireg, Merck) in combination with pembrolizumab (Keytruda, Merck) or pembrolizumab and ...