FDA publishes guidance on submission process for determining risk of investigational in vitro diagnostics

Kevan Shokat made KRAS druggable. With daraxonrasib now in the clinic, he is “all in” on the ultimate target: p53
Shokat was named 2026 Stephenson Global Prize winner

Kevan Shokat, a professor of cellular and molecular pharmacology at UC San Francisco, has won the second annual Stephenson Global Prize for research in pancreatic cancer.

October 23, 2026

Vol.52 No.39

Regulatory News

Dostarlimab becomes first FDA-approved immunotherapy for locally advanced rectal cancer
Patients now have an alternative to the brutal, life-altering standard of care

FDA has granted an accelerated approval to dostarlimab-gxly (Jemperli), making it the first and only immunotherapy approved in the U.S. for adults with locally advanced rectal cancers.

October 23, 2026

Vol.52 No.39

By Claire Marie Porter

Capitol Hill

Iowa’s “cancer crisis” emerges as a top issue on the campaign trail

“As Iowa goes, so goes the nation.”

California’s Prop 38 is an historic approach to funding medical research, immunology
The $8.4B bond makes a long-term investment in a field with life-saving power

Throughout my career as a physician and scientist, I’ve seen ideas once considered impossible become breakthroughs that save lives. They happened because talented scientists had the resources, institutions, and sustained support to pursue ambitious ideas. Most importantly, they knew patients could not afford to wait.

October 23, 2026

Vol.52 No.39

By Arie S. Belldegrun

National Academy of Medicine announces new members for 2027
The list includes Anthony Letai, Kathleen Burns, William Frist, Roy Herbst, Ross Levine, Fred Ramsdell, Dennis Slamon, Elizabeth Swisher, Albert Koong, Charles Roberts

The National Academy of Medicine announced the election of 90 regular members and 10 international members during its annual meeting Oct. 19.

October 23, 2026

Vol.52 No.39

Moving beyond escalation to a new therapeutic strategy in oncology
Microbiome-based treatment may offer a different approach

Cancer therapy has become increasingly personalized. Biomarker-driven treatment selection, targeted therapies, and immunotherapy have transformed outcomes across many tumor types and demonstrated the power of matching the right treatment to the right patient.

October 23, 2026

Vol.52 No.39

By Sumanta Pal

FDA publishes guidance on submission process for determining risk of investigational in vitro diagnostics

YOU MAY BE INTERESTED IN

Kevan Shokat made KRAS druggable. With daraxonrasib now in the clinic, he is “all in” on the ultimate target: p53
Shokat was named 2026 Stephenson Global Prize winner

Dostarlimab becomes first FDA-approved immunotherapy for locally advanced rectal cancer
Patients now have an alternative to the brutal, life-altering standard of care

Iowa’s “cancer crisis” emerges as a top issue on the campaign trail

California’s Prop 38 is an historic approach to funding medical research, immunology
The $8.4B bond makes a long-term investment in a field with life-saving power

National Academy of Medicine announces new members for 2027
The list includes Anthony Letai, Kathleen Burns, William Frist, Roy Herbst, Ross Levine, Fred Ramsdell, Dennis Slamon, Elizabeth Swisher, Albert Koong, Charles Roberts

Moving beyond escalation to a new therapeutic strategy in oncology
Microbiome-based treatment may offer a different approach

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FDA publishes guidance on submission process for determining risk of investigational in vitro diagnostics

YOU MAY BE INTERESTED IN

Kevan Shokat made KRAS druggable. With daraxonrasib now in the clinic, he is “all in” on the ultimate target: p53Shokat was named 2026 Stephenson Global Prize winner

Dostarlimab becomes first FDA-approved immunotherapy for locally advanced rectal cancerPatients now have an alternative to the brutal, life-altering standard of care

Iowa’s “cancer crisis” emerges as a top issue on the campaign trail

California’s Prop 38 is an historic approach to funding medical research, immunologyThe $8.4B bond makes a long-term investment in a field with life-saving power

National Academy of Medicine announces new members for 2027The list includes Anthony Letai, Kathleen Burns, William Frist, Roy Herbst, Ross Levine, Fred Ramsdell, Dennis Slamon, Elizabeth Swisher, Albert Koong, Charles Roberts

Moving beyond escalation to a new therapeutic strategy in oncologyMicrobiome-based treatment may offer a different approach

Never miss an issue!

Login

Kevan Shokat made KRAS druggable. With daraxonrasib now in the clinic, he is “all in” on the ultimate target: p53
Shokat was named 2026 Stephenson Global Prize winner

Dostarlimab becomes first FDA-approved immunotherapy for locally advanced rectal cancer
Patients now have an alternative to the brutal, life-altering standard of care

California’s Prop 38 is an historic approach to funding medical research, immunology
The $8.4B bond makes a long-term investment in a field with life-saving power

National Academy of Medicine announces new members for 2027
The list includes Anthony Letai, Kathleen Burns, William Frist, Roy Herbst, Ross Levine, Fred Ramsdell, Dennis Slamon, Elizabeth Swisher, Albert Koong, Charles Roberts

Moving beyond escalation to a new therapeutic strategy in oncology
Microbiome-based treatment may offer a different approach