Of adaptive and factorial designs A biostatistician’s interpretation of last week’s ODAC

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.

FDA approves durvalumab for muscle invasive bladder cancer

FDA approved AstraZeneca’s durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer.

April 04, 2025

Vol.51 No.13

Capitol Hill

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

The U.S. Department of Health and Human Services announced that it is making sweeping revisions by cutting personnel, centralizing functions, and consolidating divisions.

March 28, 2025

Vol.51 No.12

By Claire Marie Porter and Jacquelyn Cobb

Of adaptive and factorial designs

A biostatistician’s interpretation of last week’s ODAC

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

FDA approves durvalumab for muscle invasive bladder cancer

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

Renew today!

Subscriber content

Never miss an issue!

Login

Of adaptive and factorial designs

A biostatistician’s interpretation of last week’s ODAC

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

FDA approves durvalumab for muscle invasive bladder cancer

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hitAlso this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

Never miss an issue!

Login

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology