FDA grants Fast Track designation to Suplexa in MSI-H CRC

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications
Critics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

In a recent set of regulatory decisions that culminated in the resignation of FDA Commissioner Marty Makary on May 12, the agency appears to have reversed its hard-ball stance on flavored e-cigarettes.

After a year-long reign over tumult at FDA, Makary heads for the exit
Fruit-flavored e-cigs were the final blow for the commissioner

The immediate impetus for FDA Commissioner Marty Makary’s exit from the top job at FDA is arguably less significant than the legacy of dysfunction he leaves behind.

May 15, 2026

Vol.52 No.19

By Claire Marie Porter

Drugs & Targets

FDA approves oral combination Inqovi plus venetoclax for newly diagnosed AML

FDA approved an oral combination of Inqovi (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia who are 75 years or older or who are ineligible for intensive induction chemotherapy.

May 15, 2026

Vol.52 No.19

Drugs & Targets

Bizengri gets FDA approval for bile cancer, becomes seventh drug approved under the priority voucher program

FDA approved Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma.

May 15, 2026

Vol.52 No.19

Drugs & Targets

FDA clears AI digital pathology risk stratification tool in breast cancer

FDA cleared ArteraAI Breast, a multimodal AI-based prognostic and predictive cancer test, for use in patients with early-stage, hormone receptor-positive HER2-negative invasive breast cancer.

May 15, 2026

Vol.52 No.19

Podcast

Prasad’s “deceit,” plus, ODAC’s tough decision against biomarker-based progression assessment (for now)

In last week’s issue of The Cancer Letter, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, each had a big story: Jacquelyn wrote about the April 30 meeting of the Oncologic Drugs Advisory Committee, and Paul wrote about Vinay Prasad’s inaccurate claims on his CV.

May 13, 2026

FDA grants Fast Track designation to Suplexa in MSI-H CRC

YOU MAY BE INTERESTED IN

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications
Critics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

After a year-long reign over tumult at FDA, Makary heads for the exit
Fruit-flavored e-cigs were the final blow for the commissioner

FDA approves oral combination Inqovi plus venetoclax for newly diagnosed AML

Bizengri gets FDA approval for bile cancer, becomes seventh drug approved under the priority voucher program

FDA clears AI digital pathology risk stratification tool in breast cancer

Prasad’s “deceit,” plus, ODAC’s tough decision against biomarker-based progression assessment (for now)

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FDA grants Fast Track designation to Suplexa in MSI-H CRC

YOU MAY BE INTERESTED IN

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applicationsCritics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

After a year-long reign over tumult at FDA, Makary heads for the exitFruit-flavored e-cigs were the final blow for the commissioner

FDA approves oral combination Inqovi plus venetoclax for newly diagnosed AML

Bizengri gets FDA approval for bile cancer, becomes seventh drug approved under the priority voucher program

FDA clears AI digital pathology risk stratification tool in breast cancer

Prasad’s “deceit,” plus, ODAC’s tough decision against biomarker-based progression assessment (for now)

Never miss an issue!

Login

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications
Critics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

After a year-long reign over tumult at FDA, Makary heads for the exit
Fruit-flavored e-cigs were the final blow for the commissioner