FDA grants Orphan Drug designation to oxaliplatin delivered via RenovoCath catheter for pancreatic cancer

FDA issues a warning to retailers selling illegal tobacco products that resemble everyday items

FDA has issued warning letters to eight retailers for selling unauthorized tobacco products, including nicotine pouches and dissolvable tobacco products.

May 29, 2026

Vol.52 No.21

Cancer Policy

FDA advisory panel votes to recommend updated 2026-2027 formula for COVID-19 vaccines

The Vaccines and Related Biological Products Advisory Committee on May 28 approved the composition of COVID-19 vaccines for the 2026-2027 immunization season.

May 29, 2026

Vol.52 No.21

By Claire Marie Porter

Clinical Roundup

Adding a lower cutoff value for CA19-9 may identify additional high-risk cases of pancreatic cancer

A dual-threshold model for measuring the pancreatic tumor marker serum carbohydrate antigen 19-9 (CA19-9) identified patients with pancreatic cancer who had high-risk disease despite having low CA19-9 levels because of a genetic variation that impairs their ability to produce this biomarker.

May 29, 2026

Vol.52 No.21

Drugs & Targets

FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm

FDA has approved pivekimab sunirine-pvzy (Decnupaz), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm.

May 29, 2026

Vol.52 No.21

Drugs & Targets

FDA approves Hepcludex for chronic hepatitis delta virus infection

FDA has approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. Hepcludex is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis, liver cancer, liver failure, and even death.

May 29, 2026

Vol.52 No.21

Drugs & Targets

FDA grants Fast Track designation for STX-0712 for r/r CMML

FDA has granted Fast Track designation to STX-0712, an investigational therapy in development for the treatment of relapsed or refractory chronic myelomonocytic leukemia.

May 29, 2026

Vol.52 No.21

FDA grants Orphan Drug designation to oxaliplatin delivered via RenovoCath catheter for pancreatic cancer

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FDA issues a warning to retailers selling illegal tobacco products that resemble everyday items

FDA advisory panel votes to recommend updated 2026-2027 formula for COVID-19 vaccines

Adding a lower cutoff value for CA19-9 may identify additional high-risk cases of pancreatic cancer

FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm

FDA approves Hepcludex for chronic hepatitis delta virus infection

FDA grants Fast Track designation for STX-0712 for r/r CMML

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