Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two
“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

A year ago, when he was sworn in as director of the National Cancer Institute, Anthony G. Letai set a goal: Reassure cancer researchers that the institute will keep a steady course aimed at finding treatments for cancer.

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

Nearly two years after FDA issued a final rule requiring radiologists to tell women whether their breasts are “dense” or “not dense” after a mammogram, the notification has become nearly universal.

October 02, 2026

Vol.52 No.36

By Claire Marie Porter

Clinical Regulatory News

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”

For the past four decades, psilocybin research has focused on one area: the treatment of mental health disorders, including depression, anxiety, existential distress associated with serious medical illnesses, post-traumatic stress disorder, and addiction.

NIH introduces “Linked Discoveries,” a PubMed tool aimed at strengthening research replication, reproducibility

NIH has introduced Linked Discoveries, an experimental tool designed to help scientists more easily see how an individual research finding relates to the larger body of biomedical evidence.

October 02, 2026

Vol.52 No.36

In Brief

ARPA-H launches SURPASS program to accelerate clinical trials

ARPA-H launched the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, together with three complementary projects, aimed at removing barriers that slow clinical development and help promising treatments reach patients sooner.

October 02, 2026

Vol.52 No.36

Drugs & Targets

FDA approves Degevma, a biosimilar for cancer-related bone complications

FDA approved Degevma (denosumab-adet) as a biosimilar to Xgeva (denosumab).

October 02, 2026

Vol.52 No.36

Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment

YOU MAY BE INTERESTED IN

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two
“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”

NIH introduces “Linked Discoveries,” a PubMed tool aimed at strengthening research replication, reproducibility

ARPA-H launches SURPASS program to accelerate clinical trials

FDA approves Degevma, a biosimilar for cancer-related bone complications

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Pragmatica-Lung, a landmark pragmatic trial with registrational intent, starts enrollment

YOU MAY BE INTERESTED IN

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy“Because it works in one neural system, you begin to wonder: Well, what about another?”

NIH introduces “Linked Discoveries,” a PubMed tool aimed at strengthening research replication, reproducibility

ARPA-H launches SURPASS program to accelerate clinical trials

FDA approves Degevma, a biosimilar for cancer-related bone complications

Never miss an issue!

Login

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two
“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”