March 29, 2021 05:19 PM EDTUpdated April 3, 11:33 AM

FDA busts Merck's Keytruda in triple-negative breast cancer with a CRL — not unexpected given its disastrous adcomm

Kyle Blankenship

Merck and the FDA have engaged in a high-noon standoff over checkpoint inhibitor Keytruda in triple-negative breast cancer after the agency roundly panned its results …

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

BECOME A PREMIUM SUBSCRIBER

FDA busts Merck's Keytruda in triple-negative breast cancer with a CRL — not unexpected given its disastrous adcomm

Kyle Blankenship

Sign up to read this article for free.

NewAmsterdam aces Phase 3 trial, but investors are skeptical

Post-Hoc: RFK vs. Vivek, and the future of US drug policy

FDA updates label of 33-year-old cancer drug with new dose and warning

Pfizer partners with two more Flagship biotechs on obesity, cancer

When generative AI meets the FDA: First digital health adcomm kicks off discussion

Are programs with compounded GLP-1s safe for your population?

FDA busts Mer­ck­'s Keytru­da in triple-neg­a­tive breast can­cer with a CRL — not un­ex­pect­ed giv­en its dis­as­trous ad­comm

Kyle Blankenship

Sign up to read this article for free.

NewAms­ter­dam aces Phase 3 tri­al, but in­vestors are skep­ti­cal

Post-Hoc: RFK vs. Vivek, and the fu­ture of US drug pol­i­cy

FDA up­dates la­bel of 33-year-old can­cer drug with new dose and warn­ing

Pfiz­er part­ners with two more Flag­ship biotechs on obe­si­ty, can­cer

When gen­er­a­tive AI meets the FDA: First dig­i­tal health ad­comm kicks off dis­cus­sion

Are pro­grams with com­pound­ed GLP-1s safe for your pop­u­la­tion?

FDA busts Merck's Keytruda in triple-negative breast cancer with a CRL — not unexpected given its disastrous adcomm

NewAmsterdam aces Phase 3 trial, but investors are skeptical

Post-Hoc: RFK vs. Vivek, and the future of US drug policy

FDA updates label of 33-year-old cancer drug with new dose and warning

Pfizer partners with two more Flagship biotechs on obesity, cancer

When generative AI meets the FDA: First digital health adcomm kicks off discussion

Are programs with compounded GLP-1s safe for your population?