FDA grants orphan drug designation for CLN-049 in r/r AML

FDA’s acting drug chief, acting vaccines chief, and chief of staff ousted in the wake of Makary departure

In further major FDA shake-ups, three top regulators left the agency on May 15, just days after the resignation of Commissioner Marty Makary.

May 22, 2026

Vol.52 No.20

By Claire Marie Porter

Drugs & Targets

FDA approves Enhertu in HER2+ early breast cancer for both neoadjuvant and adjuvant treatment

FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively.

May 22, 2026

Vol.52 No.20

Drugs & Targets

FDA approves Signatera CDx as a companion diagnostic in muscle-invasive bladder cancer

FDA approved Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab (Tecentriq) immunotherapy in muscle-invasive bladder cancer.

May 22, 2026

Vol.52 No.20

Drugs & Targets

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

FDA has granted Hyrnuo (sevabertinib) priority review status for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations in patients with no prior therapy.

May 22, 2026

Vol.52 No.20

Podcast

The Cancer History Project debuts first de novo book; meanwhile, FDA snafus continue

In last week’s issue of The Cancer Letter, the cover story featured something special: The first de novo book published by The Cancer History Project. The book, “Backwater to Blockbuster: St. Jude Children’s Research Hospital,” co-written by Charles J. Sherr and William E. Evans, chronicles the previously untold story of St. Jude Children’s Research Hospital and its rise to becoming a global leader in pediatric cancer research.

May 20, 2026

Clinical

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications
Critics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

In a recent set of regulatory decisions that culminated in the resignation of FDA Commissioner Marty Makary on May 12, the agency appears to have reversed its hard-ball stance on flavored e-cigarettes.

May 15, 2026

Vol.52 No.19

By Sara Willa Ernst

FDA grants orphan drug designation for CLN-049 in r/r AML

YOU MAY BE INTERESTED IN

FDA’s acting drug chief, acting vaccines chief, and chief of staff ousted in the wake of Makary departure

FDA approves Enhertu in HER2+ early breast cancer for both neoadjuvant and adjuvant treatment

FDA approves Signatera CDx as a companion diagnostic in muscle-invasive bladder cancer

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

The Cancer History Project debuts first de novo book; meanwhile, FDA snafus continue

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications
Critics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

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FDA grants orphan drug designation for CLN-049 in r/r AML

YOU MAY BE INTERESTED IN

FDA’s acting drug chief, acting vaccines chief, and chief of staff ousted in the wake of Makary departure

FDA approves Enhertu in HER2+ early breast cancer for both neoadjuvant and adjuvant treatment

FDA approves Signatera CDx as a companion diagnostic in muscle-invasive bladder cancer

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

The Cancer History Project debuts first de novo book; meanwhile, FDA snafus continue

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applicationsCritics say policies clear the way for major tobacco companies to enter fruit-flavored vape market

Never miss an issue!

Login

FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications
Critics say policies clear the way for major tobacco companies to enter fruit-flavored vape market