FDA Commissioner Makary holds roundtable discussion on harms of talc

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.

Prasad’s stricter FDA policy for COVID-19 vaccines could limit future access

FDA—under the leadership of cyber-iconoclast and new director of the agency’s Center for Biologics Evaluation and Research, Vinay Prasad—is taking a new approach to COVID-19 vaccines.

May 23, 2025

Vol.51 No.20

By Claire Marie Porter

Drugs & Targets

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

FDA has approved Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who received prior systemic therapy. Avmapki Fakzynja Co-Pack is the first and only FDA-approved medicine for this disease.

May 23, 2025

Vol.51 No.20

Drugs & Targets

Cardiac CT scanner receives FDA clearance

Arineta, a provider of cardiovascular imaging solutions, announced that its SpotLight Duo cardiac CT scanner has received 510(k) clearance from FDA for low-dose lung cancer screening. This clearance allows providers to use a single ultra-fast CT platform for both cardiac and lung imaging and diagnostics, delivering more complete care to high-risk patients.

May 23, 2025

Vol.51 No.20

Drugs & Targets

FDA approves Emrelis for previously treated, advanced NSCLC with high c-Met protein overexpression

FDA granted accelerated approival to Emrelis (telisotuzumab vedotin-tllv) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression who have received a prior systemic therapy.

May 16, 2025

Vol.51 No.19

Drugs & Targets

FDA approves Zynyz as first-line treatment for advanced anal cancer

FDA approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1, in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.

May 16, 2025

Vol.51 No.19

FDA Commissioner Makary holds roundtable discussion on harms of talc

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ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

Prasad’s stricter FDA policy for COVID-19 vaccines could limit future access

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

Cardiac CT scanner receives FDA clearance

FDA approves Emrelis for previously treated, advanced NSCLC with high c-Met protein overexpression

FDA approves Zynyz as first-line treatment for advanced anal cancer

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