First FDA-approved robot-assisted microsurgery for head-and-neck cancer performed at Cedars-Sinai

Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT

FDA Commissioner Marty Makary and Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, jointly published a letter in The New England Journal of Medicine spelling out the rationale for FDA’s new “plausible mechanism pathway,” aimed at getting bespoke therapies to market without the need for a randomized controlled trial.

November 21, 2025

By Jacquelyn Cobb

Drugs & Targets

FDA grants full approval of Imdelltra in ES-SCLC

FDA granted full approval to Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. The decision to convert Imdelltra’s prior accelerated approval to a full approval is based on data from the global phase III DeLLphi-304 study.

November 21, 2025

Drugs & Targets

FDA approves Poherdy, first biosimilar to Perjeta, for breast cancer indication

FDA approved Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Perjeta (pertuzumab). This is the first approval of a biosimilar for Perjeta.

November 21, 2025

Drugs & Targets

FDA approves epcoritamab-bysp for follicular lymphoma indications

FDA approved epcoritamab-bysp with lenalidomide and rituximab for relapsed or refractory follicular lymphoma.

November 21, 2025

Drugs & Targets

FDA approves Hyrnuo for HER2-mutated NSCLC

FDA has approved Hyrnuo (sevabertinib), an oral, reversible, tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

November 21, 2025

Podcast

Ellen Sigal and Karen Knudsen “gush” about new CDER Director Richard Pazdur and his late wife, Mary

Last week, Richard Pazdur was named to the position of director of FDA’s Center for Drug Evaluation and Research. Much has been written about how Pazdur, with nearly a three-decade long career at the agency, represents a stabilizing choice for FDA as it faces inner and outer turmoil.

November 19, 2025

First FDA-approved robot-assisted microsurgery for head-and-neck cancer performed at Cedars-Sinai

YOU MAY BE INTERESTED IN

Makary, Prasad describe FDA’s new “plausible mechanism pathway” to get bespoke therapies to market sans RCT

FDA grants full approval of Imdelltra in ES-SCLC

FDA approves Poherdy, first biosimilar to Perjeta, for breast cancer indication

FDA approves epcoritamab-bysp for follicular lymphoma indications

FDA approves Hyrnuo for HER2-mutated NSCLC

Ellen Sigal and Karen Knudsen “gush” about new CDER Director Richard Pazdur and his late wife, Mary

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