House Energy and Commerce Committee Democratic leaders urge FDA to advance clinical trial diversity efforts

FDA grants accelerated approval to Zegfrovy for NSCLC with EGFR exon20ins

FDA has approved Zegfrovy (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

July 03, 2025

Vol.51 No.26

Drugs & Targets

FDA grants accelerated approval to linvoseltamab-gcpt for r/r MM

FDA has granted accelerated approval to linvoseltamab-gcpt, trade name Lynozyfic, a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

July 03, 2025

Vol.51 No.26

Drugs & Targets

REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated

FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is no longer necessary to ensure that the benefits of these CAR T-cell immunotherapies outweigh their risks and to minimize the burden on the healthcare delivery system of complying with the REMS.

July 03, 2025

Vol.51 No.26

Capitol Hill

At House hearing, Democrats clash with RFK Jr. over “radical obstruction of congressional oversight,” vaccine policies
Rep. Lori Trahan: “People are going to die”

Secretary of the U.S. Department of Health and Human Services Robert F. Kennedy Jr. appeared before the House Energy and Commerce Subcommittee on Health to defend the HHS fiscal year 2026 budget proposal, and faced criticism from several Democratic lawmakers on what they described as a lack of transparency and scientific rigor in the agency’s recent decisions.

June 27, 2025

Vol.51 No.25

By Claire Marie Porter

Cancer Policy

Jacqueline Corrigan-Curay to retire as acting head of CDER at FDA

Jacqueline Corrigan-Curay, the acting director of the Center for Drug Evaluation and Research wrote in an email to colleagues that she will be retiring from the agency in July.

June 27, 2025

Vol.51 No.25

By Claire Marie Porter

Drugs & Targets

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated NSCLC

FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.

June 27, 2025

Vol.51 No.25

House Energy and Commerce Committee Democratic leaders urge FDA to advance clinical trial diversity efforts

YOU MAY BE INTERESTED IN

FDA grants accelerated approval to Zegfrovy for NSCLC with EGFR exon20ins

FDA grants accelerated approval to linvoseltamab-gcpt for r/r MM

REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated

At House hearing, Democrats clash with RFK Jr. over “radical obstruction of congressional oversight,” vaccine policies
Rep. Lori Trahan: “People are going to die”

Jacqueline Corrigan-Curay to retire as acting head of CDER at FDA

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated NSCLC

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House Energy and Commerce Committee Democratic leaders urge FDA to advance clinical trial diversity efforts

YOU MAY BE INTERESTED IN

FDA grants accelerated approval to Zegfrovy for NSCLC with EGFR exon20ins

FDA grants accelerated approval to linvoseltamab-gcpt for r/r MM

REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated

At House hearing, Democrats clash with RFK Jr. over “radical obstruction of congressional oversight,” vaccine policiesRep. Lori Trahan: “People are going to die”

Jacqueline Corrigan-Curay to retire as acting head of CDER at FDA

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated NSCLC

Never miss an issue!

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At House hearing, Democrats clash with RFK Jr. over “radical obstruction of congressional oversight,” vaccine policies
Rep. Lori Trahan: “People are going to die”