RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state” Whistleblowers will be “honored”

RFK Jr. floats the idea of barring government scientists from publishing in leading medical journals due to “corruption”

HHS Secretary Robert F. Kennedy Jr. said he is considering a ban on government scientists publishing their work in top-tier medical journals, which he says are abed with pharmaceutical companies.

May 30, 2025

Vol.51 No.21

By Claire Marie Porter

Cancer Policy

MAHA report “Making our Children Healthy Again” focuses on ultraprocessed foods and is mum on tobacco

A recent report from the Make America Healthy Again Commission cites ultraprocessed foods, electromagnetic radiation, and herbicides as possible reasons for increased cancer incidence in children.

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.

May 23, 2025

Vol.51 No.20

By Jacquelyn Cobb

RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state”

Whistleblowers will be “honored”

YOU MAY BE INTERESTED IN

RFK Jr. floats the idea of barring government scientists from publishing in leading medical journals due to “corruption”

MAHA report “Making our Children Healthy Again” focuses on ultraprocessed foods and is mum on tobacco

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

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

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

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

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