FDA grants Fast Track designation to PDS0101 + Keytruda in recurrent or metastatic HPV16-positive HNC

FDA offers funding for meetings on medical policy activities

FDA Center for Drug Evaluation and Research is soliciting grant applications from independent organizations to support meetings that bring together a broad range of stakeholders to explore, research, and address issues related to medical products, policy, and surveillance methods and systems.

April 19, 2024

Vol.50 No.16

Drugs & Targets

FDA approves Alecensa for ALK-positive early-stage lung cancer

FDA approved Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test.

April 19, 2024

Vol.50 No.16

Drugs & Targets

FDA approves Lumisight to assist breast cancer detection

FDA approved Lumisight (pegulicianine) in adults with breast cancer to assist the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

April 19, 2024

Vol.50 No.16

Drugs & Targets

FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors

FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

April 12, 2024

Vol.50 No.15

White House

White House misses deadline to finalize FDA rule banning menthol cigarettes, prompting lawsuit from health groups

A coalition of health and physician groups earlier this week filed a lawsuit seeking to force FDA to finalize a long-delayed final rule banning menthol cigarettes.

FDA approves Abecma for earlier lines of treatment for MM

FDA approved Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial (The Cancer Letter, March 22, 2024).

April 05, 2024

Vol.50 No.14

FDA grants Fast Track designation to PDS0101 + Keytruda in recurrent or metastatic HPV16-positive HNC

YOU MAY BE INTERESTED IN

FDA offers funding for meetings on medical policy activities

FDA approves Alecensa for ALK-positive early-stage lung cancer

FDA approves Lumisight to assist breast cancer detection

FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors

White House misses deadline to finalize FDA rule banning menthol cigarettes, prompting lawsuit from health groups

FDA approves Abecma for earlier lines of treatment for MM

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