Prasad’s stricter FDA policy for COVID-19 vaccines could limit future access

HHS halts nearly $500M in mRNA-related vaccine contracts

The Department of Health and Human Services has announced the start of a reduction in its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority.

August 08, 2025

Vol.51 No.31

By Claire Marie Porter

Drugs & Targets

FDA gives accelerated approval to Modeyso as the first and only treatment for recurrent H3 K27M-mutant diffuse midline glioma

FDA granted accelerated approval for Modeyso (dordaviprone) for the treatment of adult and pediatric patients (1 year of age and older) with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

August 08, 2025

Vol.51 No.31

News Analysis

Vinay Prasad falls from grace at FDA upon flunking Trump political purity test
MAHA leaders agree on one point: COVID was mishandled. Is that enough to run science-based agencies?

It’s not a good week to be Vinay Prasad.

August 01, 2025

Vol.51 No.30

By Claire Marie Porter

Clinical Roundup

Respiratory viruses can wake up breast cancer cells in lungs, preclinical study shows

Common respiratory infections, including COVID-19 and influenza, can awaken dormant breast cancer cells that have spread to the lungs, setting the stage for new metastatic tumors, according to a preclinical study by researchers at the University of Colorado Anschutz Medical Campus, Montefiore Einstein Comprehensive Cancer Center, and Utrecht University.

August 01, 2025

Vol.51 No.30

Drugs & Targets

FDA grants priority review for Imfinzi in gastric and GEJ cancer

Imfinzi (durvalumab) has been accepted and granted Priority Review by the FDA for the treatment of patients with resectable, early-stage, and locally advanced (stages 2, 3, 4a) gastric and gastroesophageal junction cancers.

August 01, 2025

Vol.51 No.30

Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER director
His appointment came out of “proximity” to Makary and Bhattacharya

In a move that will have direct impact on approval of cancer drugs, George Francis Tidmarsh, an oncologist and a longtime pharmaceutical executive, was named director of the FDA Center for Drug Evaluation and Research.

July 25, 2025

Vol.51 No.29

By Claire Marie Porter

Prasad’s stricter FDA policy for COVID-19 vaccines could limit future access

YOU MAY BE INTERESTED IN

HHS halts nearly $500M in mRNA-related vaccine contracts

FDA gives accelerated approval to Modeyso as the first and only treatment for recurrent H3 K27M-mutant diffuse midline glioma

Vinay Prasad falls from grace at FDA upon flunking Trump political purity test
MAHA leaders agree on one point: COVID was mishandled. Is that enough to run science-based agencies?

Respiratory viruses can wake up breast cancer cells in lungs, preclinical study shows

FDA grants priority review for Imfinzi in gastric and GEJ cancer

Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER director
His appointment came out of “proximity” to Makary and Bhattacharya

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Prasad’s stricter FDA policy for COVID-19 vaccines could limit future access

YOU MAY BE INTERESTED IN

HHS halts nearly $500M in mRNA-related vaccine contracts

FDA gives accelerated approval to Modeyso as the first and only treatment for recurrent H3 K27M-mutant diffuse midline glioma

Vinay Prasad falls from grace at FDA upon flunking Trump political purity testMAHA leaders agree on one point: COVID was mishandled. Is that enough to run science-based agencies?

Respiratory viruses can wake up breast cancer cells in lungs, preclinical study shows

FDA grants priority review for Imfinzi in gastric and GEJ cancer

Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER directorHis appointment came out of “proximity” to Makary and Bhattacharya

Never miss an issue!

Login

Vinay Prasad falls from grace at FDA upon flunking Trump political purity test
MAHA leaders agree on one point: COVID was mishandled. Is that enough to run science-based agencies?

Oncologist biotech entrepreneur George Tidmarsh joins FDA as CDER director
His appointment came out of “proximity” to Makary and Bhattacharya