FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC

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

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.

May 30, 2025

Vol.51 No.21

Drugs & Targets

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

Alligator Bioscience on May 26 announced that the European Commission granted orphan drug designation to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

May 30, 2025

Vol.51 No.21

FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC

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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

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

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