FDA approves Cologuard Plus Test for non-invasive CRC screening

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

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

Drugs & Targets

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

FDA has issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease and complete response as primary endpoints in trials evaluating drugs and biologics intended to treat patients with multiple myeloma to support approval under the accelerated approval regulations.

January 23, 2026

Vol.52 No.03

Podcast

With five-year cancer survival at an all-time high, does this mean people are living longer?

“It's really, really important that every year since 1991, cancer mortality has dropped by a little bit, and it did again!” said Paul Goldberg, editor and publisher of The Cancer Letter. “Now, mortality is a good metric, age-adjusted mortality. As far as survival, well, that's not so good.”

January 21, 2026

Clinical Health Equity

New Medicaid work requirements could lead to 1.6 million missed cancer screenings over two years

New Medicaid work requirements included in President Donald Trump’s “One Big Beautiful Bill Act” could result in as many as 1.6 million missed screenings for breast, colon, and lung cancers within the first two years, researchers at the University of Chicago reported in a paper published in JAMA Oncology earlier this month.

January 16, 2026

Vol.52 No.02

By Sara Willa Ernst

FDA approves Cologuard Plus Test for non-invasive CRC screening

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

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

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

With five-year cancer survival at an all-time high, does this mean people are living longer?

New Medicaid work requirements could lead to 1.6 million missed cancer screenings over two years

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FDA approves Cologuard Plus Test for non-invasive CRC screening

YOU MAY BE INTERESTED IN

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

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

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

With five-year cancer survival at an all-time high, does this mean people are living longer?

New Medicaid work requirements could lead to 1.6 million missed cancer screenings over two years

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