Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down
The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

Recently, HHS Secretary Robert F. Kennedy Jr. posted a video montage featuring himself shirtless in jeans, working out with Kid Rock. The duo is in a blue-lit grotto with a cold plunge and sauna. Set to Kid Rock’s “Bawitdaba” and intercut with a selection of patriotic imagery, the video ends with the two men in a hot tub, chugging what appears to be milk.

April 03, 2026

Vol.52 No.13

By Claire Marie Porter

Guest Editorial

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.” This release came roughly 20 months after the Oncologic Drugs Advisory Committee (ODAC) voted unanimously that minimal residual disease (MRD) negativity, in combination with complete response (CR), is an acceptable primary endpoint to support accelerated approval for multiple myeloma (MM) therapies.

April 03, 2026

Vol.52 No.13

By Nicholas Richardson

Cancer Policy

Trump imposes up to 100% tariff on some brand name pharmaceutical companies

President Donald Trump has imposed a 100% tariff on drugmakers that have not struck a deal with the president to lower the U.S. drug prices of patented pharmaceutical products and ingredients.

April 03, 2026

Vol.52 No.13

By Claire Marie Porter

Drugs & Targets

FDA approves Tecartus for r/r mantle cell lymphoma

FDA granted full approval to Tecartus (brexucabtagene autoleucel), Kite’s CAR T-cell therapy, for adult patients with relapsed or refractory mantle cell lymphoma.

April 03, 2026

Vol.52 No.13

Drugs & Targets

FDA approves Ponlimsi to increase bone mass, including for breast and prostate cancer patients

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

April 03, 2026

Vol.52 No.13

Drugs & Targets

FDA grants priority review to Elevar Therapeutics’s lirafugratinib as second-line cholangiocarcinoma treatment

FDA granted priority review to lirafugratinib, an investigational therapy, for the treatment of patients with cholangiocarcinoma with FGFR2 fusions or rearrangements who have received prior therapy.

April 03, 2026

Vol.52 No.13

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology

Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

YOU MAY BE INTERESTED IN

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down
The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

Trump imposes up to 100% tariff on some brand name pharmaceutical companies

FDA approves Tecartus for r/r mantle cell lymphoma

FDA approves Ponlimsi to increase bone mass, including for breast and prostate cancer patients

FDA grants priority review to Elevar Therapeutics’s lirafugratinib as second-line cholangiocarcinoma treatment

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Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology

Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

YOU MAY BE INTERESTED IN

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside downThe Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters mostDraft guidance consolidates trial design updates for developers

Trump imposes up to 100% tariff on some brand name pharmaceutical companies

FDA approves Tecartus for r/r mantle cell lymphoma

FDA approves Ponlimsi to increase bone mass, including for breast and prostate cancer patients

FDA grants priority review to Elevar Therapeutics’s lirafugratinib as second-line cholangiocarcinoma treatment

Never miss an issue!

Login

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down
The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers