Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

FDA delays drug reviews in new voucher program amid safety, efficacy concerns

The reviews of two drugs granted priority review via FDA’s new priority voucher program, Commissioner’s National Priority Voucher (CNPV) Pilot Program, have been delayed.

January 30, 2026

Vol.52 No.04

By Claire Marie Porter

Clinical Roundup

UCLA launches trial comparing two types of PSMA radiopharmaceuticals for recurrent prostate cancer

Investigators at the UCLA Health Jonsson Comprehensive Cancer Center have opened a clinical trial that will look at whether combining precision radiation with a targeted radioactive therapy drug can help patients with recurrent prostate cancer delay progression, while delaying or avoiding the side effects of long-term hormone therapy.

January 30, 2026

Vol.52 No.04

Drugs & Targets

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

FDA has approved Darzalez Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility.

January 30, 2026

Vol.52 No.04

Clinical

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

A story is told that after first obtaining approval for marketing Premarin in 1942, Wyeth Laboratories didn’t lock up the secret recipe for making the hormonal drug in a company safe, to be guarded by patent lawyers.

January 23, 2026

Vol.52 No.03

By Claire Marie Porter

Opening doors to immunotherapy in prostate cancer: A roadmap from clinic to community

Prostate cancer remains a formidable challenge, particularly in its advanced stages, where bone metastases and treatment resistance dominate outcomes. At City of Hope, our focus is on leveraging immunotherapy to transform this landscape.

January 23, 2026

Vol.52 No.03

By Tanya Dorff

Clinical Roundup

Researchers develop tool that can identify high- and low-risk metastatic prostate cancer patients earlier

A multi-institutional research team has developed one of the first validated tools to predict before treatment if a patient will have a favorable biochemical response in patients with metastatic hormone-sensitive prostate cancer.

January 23, 2026

Vol.52 No.03

Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

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FDA delays drug reviews in new voucher program amid safety, efficacy concerns

UCLA launches trial comparing two types of PSMA radiopharmaceuticals for recurrent prostate cancer

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

Opening doors to immunotherapy in prostate cancer: A roadmap from clinic to community

Researchers develop tool that can identify high- and low-risk metastatic prostate cancer patients earlier

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Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

YOU MAY BE INTERESTED IN

FDA delays drug reviews in new voucher program amid safety, efficacy concerns

UCLA launches trial comparing two types of PSMA radiopharmaceuticals for recurrent prostate cancer

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

Premarin’s 84-year hold on the market ends as FDA approves a generic versionTrade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

Opening doors to immunotherapy in prostate cancer: A roadmap from clinic to community

Researchers develop tool that can identify high- and low-risk metastatic prostate cancer patients earlier

Never miss an issue!

Login

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer