Annals of Unintended Consequences: How FDA regulations undermine the biosimilar marketplace and the BPCIA

FDA clears first HPV self-collection kit and assay for at-home use, marking a step toward improving screening uptake

FDA cleared Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening and removing barriers that currently prevent many individuals from receiving routine screening.

April 10, 2026

Vol.52 No.14

Drugs & Targets

Nuvalent submits NDA to FDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC

Nuvalent announced the submission of a New Drug Application to FDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive non-small cell lung cancer.

April 10, 2026

Vol.52 No.14

News Analysis

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Draft guidance consolidates trial design updates for developers

In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.”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

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

Annals of Unintended Consequences: How FDA regulations undermine the biosimilar marketplace and the BPCIA

YOU MAY BE INTERESTED IN

FDA clears first HPV self-collection kit and assay for at-home use, marking a step toward improving screening uptake

Nuvalent submits NDA to FDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC

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

FDA approves Tecartus for r/r mantle cell lymphoma

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

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Annals of Unintended Consequences: How FDA regulations undermine the biosimilar marketplace and the BPCIA

YOU MAY BE INTERESTED IN

FDA clears first HPV self-collection kit and assay for at-home use, marking a step toward improving screening uptake

Nuvalent submits NDA to FDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC

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

FDA approves Tecartus for r/r mantle cell lymphoma

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

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