FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

In The Headlines: Back to “business as usual” at FDA?

The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.

May 28, 2025

Regulatory News

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.

FDA Commissioner Makary holds roundtable discussion on harms of talc

FDA Commissioner Marty Makary held a roundtable of independent scientific experts to discuss the safety and necessity of talc as an additive to food, drugs, and cosmetic products.

May 23, 2025

Vol.51 No.20

By Claire Marie Porter

Cancer Policy

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

FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

YOU MAY BE INTERESTED IN

In The Headlines: Back to “business as usual” at FDA?

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

FDA Commissioner Makary holds roundtable discussion on harms of talc

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

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