FDA grants priority review to Tibsovo in combination with azacitidine in previously untreated IDH1-mutated AML

FDA booth stood empty at 2025 ASCO annual meeting

Booth 10025 became an unlikely crowd magnet at the exhibit hall at the annual meeting of the American Society of Clinical Oncology that ended earlier this week.

Makary: Level of evidence is an artificial and dogmatic construct

Mehmet Oz, Robert F. Kennedy Jr., Marty Makary, Jayanta Bhattacharya, and Vinayak Prasad at an FDA Roundtable on Cell and Gene Therapy, June 5.Speaking at an FDA Roundtable on Cell and Gene Therapy, FDA Commissioner Marty Makary questioned the construct of “levels of evidence” as artificial and dogmatic, saying that n-of-1 “stories” can drive regulatory decisions.

FDA rolls out agency-wide AI tool

FDA rolled out a generative artificial intelligence tool designed to help employees across the agency “work more efficiently.”

FDA approves Nubeqa for metastatic castration-sensitive prostate cancer

FDA approved the oral androgen receptor inhibitor Nubeqa (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer, which is also known as metastatic hormone-sensitive prostate cancer.

June 06, 2025

Vol.51 No.22

Drugs & Targets

EC approves Adcetris for newly diagnosed Hodgkin lymphoma in combination with ECADD

The European Commission June 3 approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone—a chemotherapy regimen—in adult patients with newly diagnosed stage 2b with risk factors, stage 3, and stage 4 Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on April 25.

June 06, 2025

Vol.51 No.22

Drugs & Targets

Meitheal Pharmaceuticals launches generic paclitaxel formulation in the U.S.

Meitheal Pharmaceuticals Inc. on May 29 announced it has launched, through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd., paclitaxel protein-bound particles for injectable suspension (albumin-bound), a generic form of Abraxane, in the U.S.

June 06, 2025

Vol.51 No.22

FDA grants priority review to Tibsovo in combination with azacitidine in previously untreated IDH1-mutated AML

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FDA booth stood empty at 2025 ASCO annual meeting

Makary: Level of evidence is an artificial and dogmatic construct

FDA rolls out agency-wide AI tool

FDA approves Nubeqa for metastatic castration-sensitive prostate cancer

EC approves Adcetris for newly diagnosed Hodgkin lymphoma in combination with ECADD

Meitheal Pharmaceuticals launches generic paclitaxel formulation in the U.S.

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