FDA to increase regulatory flexibility for development of cell and gene therapies

Self-collection kits for HPV are among innovations adding momentum to eradication of cervical cancer
A kit for at-home unsupervised self-collection clears FDA finish line

Boca Raton resident Gabriela Sanchez recently found herself stepping into a mobile outreach vehicle operated by Sylvester Comprehensive Cancer Center.

April 17, 2026

Vol.52 No.15

By Claire Marie Porter

Cancer Policy

FDA adds stereotactic breast biopsy needles to the shortage list

FDA has added stereotactic breast biopsy needles to its Medical Device Shortages List with an estimated duration of “through Q4 2026,” which spans July 1 to Sept. 30.

FDA issues reminder to sponsors: Disclose clinical trial results

FDA issued a stern reminder to medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov.

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

FDA to increase regulatory flexibility for development of cell and gene therapies

YOU MAY BE INTERESTED IN

Self-collection kits for HPV are among innovations adding momentum to eradication of cervical cancer
A kit for at-home unsupervised self-collection clears FDA finish line

FDA adds stereotactic breast biopsy needles to the shortage list

FDA issues reminder to sponsors: Disclose clinical trial results

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

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FDA to increase regulatory flexibility for development of cell and gene therapies

YOU MAY BE INTERESTED IN

Self-collection kits for HPV are among innovations adding momentum to eradication of cervical cancerA kit for at-home unsupervised self-collection clears FDA finish line

FDA adds stereotactic breast biopsy needles to the shortage list

FDA issues reminder to sponsors: Disclose clinical trial results

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

Never miss an issue!

Login

Self-collection kits for HPV are among innovations adding momentum to eradication of cervical cancer
A kit for at-home unsupervised self-collection clears FDA finish line

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