ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

FDA approved Tuksya (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive breast cancer following induction treatment. The approval expands the use of Tuksya to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment option that may help further delay disease progression.

October 09, 2026

Vol.52 No.37

Regulatory News

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.

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

Drugs & Targets

FDA approves Ponlimsi, a biosimilar for preventing fractures in prostate and breast cancer patients

FDA approved Ponlimsi (denosumab-adet) as a biosimilar to Prolia.

October 02, 2026

Vol.52 No.36

Drugs & Targets

FDA accepts NDA and grants Priority Review to Lynkuet for vasomotor symptoms due to endocrine therapy in breast cancer

FDA accepted the company’s supplemental New Drug Application and granted Priority Review designation for Lynkuet (elinzanetant) under investigation for the treatment of moderate to severe vasomotor symptoms (also known as hot flashes) in women receiving endocrine therapy for treatment of breast cancer.

October 02, 2026

Vol.52 No.36

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

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FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast 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?

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?”

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

FDA approves Ponlimsi, a biosimilar for preventing fractures in prostate and breast cancer patients

FDA accepts NDA and grants Priority Review to Lynkuet for vasomotor symptoms due to endocrine therapy in breast cancer

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ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

YOU MAY BE INTERESTED IN

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

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?”

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

FDA approves Ponlimsi, a biosimilar for preventing fractures in prostate and breast cancer patients

FDA accepts NDA and grants Priority Review to Lynkuet for vasomotor symptoms due to endocrine therapy in breast cancer

Never miss an issue!

Login

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?”