Scott Gottlieb, Mark McClellan warn of the major challenges created by planned reorganization of FDA

Trump releases executive order that demands “Restoring Gold Standard Science”

President Trump has issued an executive order, titled “Restoring Gold Standard Science,” which “ensures that agencies practice data transparency, acknowledge relevant scientific uncertainties, are transparent about the assumptions and likelihood of scenarios used, approach scientific findings objectively, and communicate scientific data accurately.”

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.

May 30, 2025

Vol.51 No.21

Drugs & Targets

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

Alligator Bioscience on May 26 announced that the European Commission granted orphan drug designation to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

May 30, 2025

Vol.51 No.21

Podcast

In The Headlines: Back to “business as usual” at FDA?

The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.

May 28, 2025

Vol.51 No.20

Regulatory News

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.

FDA Commissioner Makary holds roundtable discussion on harms of talc

FDA Commissioner Marty Makary held a roundtable of independent scientific experts to discuss the safety and necessity of talc as an additive to food, drugs, and cosmetic products.

May 23, 2025

Vol.51 No.20

By Claire Marie Porter