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Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment

Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment

April 14, 2023
Vol.49 No.15
By Jacquelyn Cobb
FDA’s Fashoyin-Aje: Draft guidance on accelerated approval urges reliance on randomized controlled trials
Conversation with The Cancer LetterRegulatory News

FDA’s Fashoyin-Aje: Draft guidance on accelerated approval urges reliance on randomized controlled trials

March 31, 2023
Vol.49 No.13
By Jacquelyn Cobb
Drugs & Targets

FDA grants full approval indication for Keytruda for certain patients with advanced MSI-H or dMMR solid tumors

March 31, 2023
Vol.49 No.13
Drugs & Targets

FDA releases draft guidance aimed at improving oncology clinical trials for accelerated approval

March 24, 2023
Vol.49 No.12
Drugs & Targets

FDA grants accelerated approval to Zynyz for metastatic or recurrent locally advanced Merkel cell carcinoma

March 24, 2023
Vol.49 No.12
Drugs & Targets

FDA approves Tafinlar + Mekinist for pediatric patients with low-grade glioma with a BRAF V600E mutation

March 17, 2023
Vol.49 No.11
Improving on R-CHOP, ODAC votes 11:2 to move Genentech’s Polivy to the first line in diffuse large B-cell lymphoma
Regulatory News

Improving on R-CHOP, ODAC votes 11:2 to move Genentech’s Polivy to the first line in diffuse large B-cell lymphoma

March 10, 2023
Vol.49 No.10
By Jacquelyn Cobb
Drugs & Targets

FDA broadens indication for Verzenio in HR+, HER2-, node-positive, high-risk early breast cancer

March 10, 2023
Vol.49 No.10
Drugs & Targets

FDA approves label expansion for VENTANA PD-L1 assay to identify patients with locally advanced and metastatic NSCLC eligible for Libtayo

March 10, 2023
Vol.49 No.10
Drugs & Targets

FDA approves Udenyca autoinjector

March 10, 2023
Vol.49 No.10

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