FDA grants Breakthrough Therapy designation for Tecvayli + Darzalex Faspro as a second line treatment for r/r MM

John Byrd brings blood cancer expertise to solid tumor, immunology powerhouse at UPMC

John C. Byrd grew up in Augusta, a town of 2,000 or so in northeastern Arkansas.

December 12, 2025

FDA withdraws proposed rule for asbestos testing in talc-based cosmetics
It’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation

FDA has withdrawn a proposed rule that called for standardized testing for detecting and identifying asbestos in talc-containing cosmetic products.

December 12, 2025

Vol.51 No.45

By Claire Marie Porter

Regulatory News

ESMO publishes guidances on AI tools for clinicians, patients, and researchers
Says one author: “We think there should be some degree of human oversight, otherwise, they can go completely rogue and nobody notices.”

The European Society For Medical Oncology has formally weighed in on a question that U.S. medical groups have been chipping away at as well: How can we guarantee safe and effective use of artificial intelligence in oncology?

Harvey Risch, critic of COVID-19 response, tapped by White House to serve as chair of the President’s Cancer Panel

Harvey A. Risch, professor emeritus and senior research scientist at Yale School of Public Health, said he was named chair of the President’s Cancer Panel. Risch will succeed Elizabeth M. Jaffee, who was appointed by President Joe Biden in January 2023.

House passes Mikaela Naylon Give Kids a Chance Act—next step, the Senate

The U.S. House of Representatives unanimously passed the Mikaela Naylon Give Kids A Chance Act, a bill to accelerate pediatric cancer treatments and expand access to life-saving therapies for children battling rare diseases.

December 12, 2025

Vol.51 No.45

By Claire Marie Porter

Cancer Policy

Former FDA Commissioner Scott Gottlieb speaks out against CDC vaccine panel

Scott Gottlieb, a former FDA commissioner, said a recent decision by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices’ to change its recommendation for when children should receive the hepatitis B vaccine is another sign of the ACIP’s diminished credibility as a scientific authority.

December 12, 2025

Vol.51 No.45

By Sara Willa Ernst

FDA grants Breakthrough Therapy designation for Tecvayli + Darzalex Faspro as a second line treatment for r/r MM

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John Byrd brings blood cancer expertise to solid tumor, immunology powerhouse at UPMC

FDA withdraws proposed rule for asbestos testing in talc-based cosmetics
It’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation

ESMO publishes guidances on AI tools for clinicians, patients, and researchers
Says one author: “We think there should be some degree of human oversight, otherwise, they can go completely rogue and nobody notices.”

Harvey Risch, critic of COVID-19 response, tapped by White House to serve as chair of the President’s Cancer Panel

House passes Mikaela Naylon Give Kids a Chance Act—next step, the Senate

Former FDA Commissioner Scott Gottlieb speaks out against CDC vaccine panel

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FDA grants Breakthrough Therapy designation for Tecvayli + Darzalex Faspro as a second line treatment for r/r MM

YOU MAY BE INTERESTED IN

John Byrd brings blood cancer expertise to solid tumor, immunology powerhouse at UPMC

FDA withdraws proposed rule for asbestos testing in talc-based cosmeticsIt’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation

ESMO publishes guidances on AI tools for clinicians, patients, and researchersSays one author: “We think there should be some degree of human oversight, otherwise, they can go completely rogue and nobody notices.”

Harvey Risch, critic of COVID-19 response, tapped by White House to serve as chair of the President’s Cancer Panel

House passes Mikaela Naylon Give Kids a Chance Act—next step, the Senate

Former FDA Commissioner Scott Gottlieb speaks out against CDC vaccine panel

Never miss an issue!

Login

FDA withdraws proposed rule for asbestos testing in talc-based cosmetics
It’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation

ESMO publishes guidances on AI tools for clinicians, patients, and researchers
Says one author: “We think there should be some degree of human oversight, otherwise, they can go completely rogue and nobody notices.”