FDA clears AI digital pathology risk stratification tool in breast cancer

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

Clinical Roundup

Stage 4 breast cancer has increased in incidence and proportion over the last decade

Researchers found that cases of stage 4 breast cancer are increasing both in incidence and as a proportion of all breast cancer diagnoses, according to findings from an observational study.

May 15, 2026

Vol.52 No.19

Clinical Roundup

Cedars-Sinai leads development of AI-based tool to predict spatial gene expression in tumors

A team led by Cedars-Sinai Health Sciences University investigators has created a faster, cheaper way to determine the genes expressed in cancerous tumors. The AI-based tool could make personalized cancer treatment available to more patients.

May 15, 2026

Vol.52 No.19

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

FDA clears AI digital pathology risk stratification tool in breast cancer

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

Stage 4 breast cancer has increased in incidence and proportion over the last decade

Cedars-Sinai leads development of AI-based tool to predict spatial gene expression in tumors

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

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FDA clears AI digital pathology risk stratification tool in breast cancer

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

Stage 4 breast cancer has increased in incidence and proportion over the last decade

Cedars-Sinai leads development of AI-based tool to predict spatial gene expression in tumors

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

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