FDA approves Enhertu as first HER2-directed therapy for breast cancer

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

A federal judge ruled that the FDA lacks the statutory authority to regulate laboratory developed tests, finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs.

April 11, 2025

Vol.51 No.14

Drugs & Targets

FDA approves Vitrakvi for NTRK gene fusion-positive solid tumors

FDA granted full approval for Vitrakvi (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

April 11, 2025

Vol.51 No.14

Drugs & Targets

FDA approves Jobevne, a bevacizumab biosimilar

FDA approved Biocon Biologics Ltd’s Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for intravenous use. Jobevne, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab).

April 11, 2025

Vol.51 No.14

In the Archives

In an oral history now taken down by FDA, Andrew von Eschenbach recounts his stint as the head of both FDA and NCI—simultaneously

Credit: NCI/Linda BartlettIn an oral history conducted by FDA in September 2013, Andrew C. von Eschenbach recounted his eight-month stint in a dual role as both FDA acting commissioner and NCI director.

Less Radical, a podcast about Bernie Fisher, nominated for two Webby Awards

Less Radical, a documentary podcast that tells story of Bernie Fisher, a pioneering surgeon-scientist who redefined breast cancer treatment, was nominated for Best Podcast - Documentary and Best Indie Podcast – Limited Run in the 29th Annual Webby Awards.

April 04, 2025

Vol.51 No.13

Clinical Roundup

Mass General study: Screenings for breast and colorectal cancer 4x higher than lung cancer

Although lung cancer screening is recommended in the U.S. for certain individuals with a history of smoking, only 18% of eligible individuals in the U.S. get screened.

April 04, 2025

Vol.51 No.13

FDA approves Enhertu as first HER2-directed therapy for breast cancer

YOU MAY BE INTERESTED IN

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

FDA approves Vitrakvi for NTRK gene fusion-positive solid tumors

FDA approves Jobevne, a bevacizumab biosimilar

In an oral history now taken down by FDA, Andrew von Eschenbach recounts his stint as the head of both FDA and NCI—simultaneously

Less Radical, a podcast about Bernie Fisher, nominated for two Webby Awards

Mass General study: Screenings for breast and colorectal cancer 4x higher than lung cancer

Renew today!

Subscriber content