FDA issues draft guidance on expanded access to investigational drugs

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

The U.S. Department of Health and Human Services announced that it is making sweeping revisions by cutting personnel, centralizing functions, and consolidating divisions.

March 28, 2025

Vol.51 No.12

By Claire Marie Porter and Jacquelyn Cobb

Drugs & Targets

FDA approves cabozantinib for patients 12 and up with pNET and epNET

FDA approved cabozantinib (Cabometyx) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.

March 28, 2025

Vol.51 No.12

Drugs & Targets

FDA approves prostate cancer imaging agent Gozellix

FDA approved Gozellix (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), a next-generation PSMA-PET imaging agent for prostate cancer.

March 28, 2025

Vol.51 No.12

Drugs & Targets

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).

March 21, 2025

Vol.51 No.11

Drugs & Targets

FDA grants Orphan Drug designation to rhenium obisbemeda for leptomeningeal metastases in lung cancer

FDA granted Orphan Drug designation to rhenium obisbemeda (186Re) for the treatment of leptomeningeal metastases in patients with lung cancer.

March 14, 2025

Vol.51 No.10

Clinical Roundup

CAR T-cell therapy for B-ALL results in high incidence of durable response in phase I/II study

B-cell acute lymphoblastic leukemia is a common type of ALL in adults.

March 07, 2025

Vol.51 No.09

FDA issues draft guidance on expanded access to investigational drugs

YOU MAY BE INTERESTED IN

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

FDA approves cabozantinib for patients 12 and up with pNET and epNET

FDA approves prostate cancer imaging agent Gozellix

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

FDA grants Orphan Drug designation to rhenium obisbemeda for leptomeningeal metastases in lung cancer

CAR T-cell therapy for B-ALL results in high incidence of durable response in phase I/II study

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FDA issues draft guidance on expanded access to investigational drugs

YOU MAY BE INTERESTED IN

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hitAlso this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

FDA approves cabozantinib for patients 12 and up with pNET and epNET

FDA approves prostate cancer imaging agent Gozellix

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

FDA grants Orphan Drug designation to rhenium obisbemeda for leptomeningeal metastases in lung cancer

CAR T-cell therapy for B-ALL results in high incidence of durable response in phase I/II study

Never miss an issue!

Login

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)