FDA grants Orphan Drug Designation to iadademstat in SCLC

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

Cancer Policy

Right-wing provocateur Laura Loomer comes for FDA’s Vinay Prasad

Laura LoomerVinay PrasadRight-wing activist Laura Loomer is demanding Vinay Prasad’s ouster from FDA, calling him a “saboteur” and “trojan [sic] horse” of the administration’s “Make America Healthy Again” initiative.

July 25, 2025

Vol.51 No.29

By Claire Marie Porter

Cancer Policy

The effects of NIH, FDA cuts will be felt for decades, CBO report estimates

A report from the nonpartisan Congressional Budget Office said that proposed cuts at NIH could lead to a decrease in the number of new drugs that come to market in the next three decades.

COI statement prohibits “unseemly advocacy,” “undue influence” by industry rep on ODAC

In April, FDA Commissioner Marty Makary said that the presence of industry employees as members of FDA advisory committees “represents a cozy relationship” between FDA and the businesses it regulates.

July 25, 2025

Vol.51 No.29

By Paul Goldberg

Funding Opportunities

FDA OCE issues RFA for cooperative agreements for evaluation of cardiotoxicity

FDA’s Oncology Center of Excellence issued an RFA to support U01 cooperative agreements for applied regulatory science research to evaluate cardiotoxicity of oncology therapeutics.

July 25, 2025

Vol.51 No.29

Clinical Roundup

Tagrisso + chemo improve OS in EGFR-mutated advanced lung cancer, phase III trial shows

Tagrisso (osimertinib) plus chemotherapy delivers a statistically significant and clinically meaningful survival benefit compared to Tagrisso monotherapy in the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer, according to results from the final overall survival analysis of the FLAURA2 phase III trial.

July 25, 2025

Vol.51 No.29

FDA grants Orphan Drug Designation to iadademstat in SCLC

YOU MAY BE INTERESTED IN

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

Right-wing provocateur Laura Loomer comes for FDA’s Vinay Prasad

The effects of NIH, FDA cuts will be felt for decades, CBO report estimates

COI statement prohibits “unseemly advocacy,” “undue influence” by industry rep on ODAC

FDA OCE issues RFA for cooperative agreements for evaluation of cardiotoxicity

Tagrisso + chemo improve OS in EGFR-mutated advanced lung cancer, phase III trial shows

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FDA grants Orphan Drug Designation to iadademstat in SCLC

YOU MAY BE INTERESTED IN

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

Right-wing provocateur Laura Loomer comes for FDA’s Vinay Prasad

The effects of NIH, FDA cuts will be felt for decades, CBO report estimates

COI statement prohibits “unseemly advocacy,” “undue influence” by industry rep on ODAC

FDA OCE issues RFA for cooperative agreements for evaluation of cardiotoxicity

Tagrisso + chemo improve OS in EGFR-mutated advanced lung cancer, phase III trial shows

Never miss an issue!

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