Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER director His appointment came out of “proximity” to Makary and Bhattacharya

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

Capitol Hill

Spending bill passed by the House gives NIH $415M raise, NCI gets $128M
Legislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

The U.S. House of Representatives Jan. 22 passed a three-bill minibus package that is expected to be the grand finale of the drama of the fiscal year 2026 appropriations process. The package, which funds the HHS as well as the departments of Defense, Transportation, Housing and Urban Development, Labor, and Education, gives NIH and NCI modest raises over FY25, and nullifies several aggressive cuts the White House had proposed for NIH.

Fifth time’s a charm? Mikaela Naylon Give Kids a Chance Act is included in FY26 spending bill

Sometime next week, the Senate is expected to vote on a legislative package that would determine the fiscal year 2026 spending levels for much of the federal government. xxx:moreReaders of The Cancer Letter may be breathing a sigh of relief that NIH seems like

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval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

Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER director

His appointment came out of “proximity” to Makary and Bhattacharya

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 version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

Spending bill passed by the House gives NIH $415M raise, NCI gets $128M
Legislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

Fifth time’s a charm? Mikaela Naylon Give Kids a Chance Act is included in FY26 spending bill

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

Renew today!

Subscriber content

Never miss an issue!

Login

Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER director

His appointment came out of “proximity” to Makary and Bhattacharya

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

Spending bill passed by the House gives NIH $415M raise, NCI gets $128MLegislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

Fifth time’s a charm? Mikaela Naylon Give Kids a Chance Act is included in FY26 spending bill

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

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

Spending bill passed by the House gives NIH $415M raise, NCI gets $128M
Legislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched