FDA issues CRL for RP1+ nivolumab BLA for treatment of advanced melanoma

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

Drugs & Targets

FDA extends review period for Blenrep combinations after unfavorable ODAC vote, EU approval

FDA July 23 extended the review period for the Biologics License Application for Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

July 25, 2025

Vol.51 No.29

By Jacquelyn Cobb

FDA issues CRL for RP1+ nivolumab BLA for treatment of advanced melanoma

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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

FDA extends review period for Blenrep combinations after unfavorable ODAC vote, EU approval

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FDA issues CRL for RP1+ nivolumab BLA for treatment of advanced melanoma

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

FDA extends review period for Blenrep combinations after unfavorable ODAC vote, EU approval

Never miss an issue!

Login

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