Robert Califf’s confirmation as FDA commissioner clears Senate HELP Committee

First FDA-approved robot-assisted microsurgery for head-and-neck cancer performed at Cedars-Sinai

Cedars-Sinai performed the first robot-assisted microsurgical head-and-neck cancer reconstructive surgery in the United States after the robot device received FDA approval for the procedure.

February 21, 2025

Vol.51 No.07

Drugs & Targets

FDA grants priority review to Boehringer’s BI 1810631 for the treatment of HER2-mutant advanced NSCLC

FDA granted priority review to Boehringer Ingelheim’s new drug application for BI 1810631 (zongertinib) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have HER2 mutations and who have received prior systemic therapy.

February 21, 2025

Vol.51 No.07

White House

RFK Jr. is confirmed, NCORP stops collecting data on sexual orientation, gender
One month in: Trump’s impact on oncology

Earlier this week, Robert F. Kennedy Jr. was confirmed as secretary of Health and Human Services amid many resignations at federal health agencies and cancellations of NIH and NCAB meetings. All of this happened at a time when the Trump administration is reportedly preparing to fire thousands of HHS workers.

February 14, 2025

Vol.51 No.06

By Claire Marie Porter and Jacquelyn Cobb

Drugs & Targets

FDA approves Adcetris + lenalidomide + rituximab for r/r large B-cell lymphoma

FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.

February 14, 2025

Vol.51 No.06

Drugs & Targets

FDA approves Gomekli for pediatric patients with neurofiromatosis type 1

FDA approved Gomekli (mirdametinib), a kinase inhibitor from SpringWorks Therapeutics, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.

February 14, 2025

Vol.51 No.06

Black History Month In the Archives

Marsha Henderson: “You have to continue to push for what you think is the right thing for public health.”
Preserving an oral history by the former FDA associate commissioner of women’s heath

When Marsha B. Henderson, former FDA Associate Commissioner of Women’s Health (1998-2019), sat down for an oral history interview upon her retirement from the agency, she could not have foreseen becoming party to a government digital purge 7 years later. Over the past week, the Trump administration has been busy at work deleting government webpages...

February 07, 2025

Vol.51 No.05

By Katie Goldberg

Robert Califf’s confirmation as FDA commissioner clears Senate HELP Committee

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First FDA-approved robot-assisted microsurgery for head-and-neck cancer performed at Cedars-Sinai

FDA grants priority review to Boehringer’s BI 1810631 for the treatment of HER2-mutant advanced NSCLC

RFK Jr. is confirmed, NCORP stops collecting data on sexual orientation, gender
One month in: Trump’s impact on oncology

FDA approves Adcetris + lenalidomide + rituximab for r/r large B-cell lymphoma

FDA approves Gomekli for pediatric patients with neurofiromatosis type 1

Marsha Henderson: “You have to continue to push for what you think is the right thing for public health.”
Preserving an oral history by the former FDA associate commissioner of women’s heath

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Robert Califf’s confirmation as FDA commissioner clears Senate HELP Committee

YOU MAY BE INTERESTED IN

First FDA-approved robot-assisted microsurgery for head-and-neck cancer performed at Cedars-Sinai

FDA grants priority review to Boehringer’s BI 1810631 for the treatment of HER2-mutant advanced NSCLC

RFK Jr. is confirmed, NCORP stops collecting data on sexual orientation, genderOne month in: Trump’s impact on oncology

FDA approves Adcetris + lenalidomide + rituximab for r/r large B-cell lymphoma

FDA approves Gomekli for pediatric patients with neurofiromatosis type 1

Marsha Henderson: “You have to continue to push for what you think is the right thing for public health.”Preserving an oral history by the former FDA associate commissioner of women’s heath

Never miss an issue!

Login

RFK Jr. is confirmed, NCORP stops collecting data on sexual orientation, gender
One month in: Trump’s impact on oncology

Marsha Henderson: “You have to continue to push for what you think is the right thing for public health.”
Preserving an oral history by the former FDA associate commissioner of women’s heath