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

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

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

Drugs & Targets

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

RenovoRx Inc. received an Orphan Drug Designation of oxaliplatin for the treatment of pancreatic cancer delivered via RenovoCath device.

May 29, 2026

Vol.52 No.21

Podcast

As FDA’s wheels almost entirely come off, NCI remains sturdy—a cancer moonshot may even be on the horizon

While every agency under HHS, particularly FDA, has seen historic leadership shakeups and massive cuts to personnel and funding over the course of the second Trump administration—NCI has been spared, even getting a small raise, under the direction of NCI Director Anthony Letai.

May 27, 2026

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

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

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

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

As FDA’s wheels almost entirely come off, NCI remains sturdy—a cancer moonshot may even be on the horizon

Renew today!

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