FDA approves Jobevne, a bevacizumab biosimilar

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

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

Drugs & Targets

CHMP recommends approval of Calquence plus chemoimmunotherapy for first-line mantle cell lymphoma

AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the EU for the treatment of adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.

April 04, 2025

Vol.51 No.13

Drugs & Targets

CHMP recommends approval for Tevimbra as a first-line treatment for extensive-stage small cell lung cancer

BeiGene Ltd. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer.

April 04, 2025

Vol.51 No.13

FDA approves Jobevne, a bevacizumab biosimilar

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

FDA approves Vitrakvi for NTRK gene fusion-positive solid tumors

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

CHMP recommends approval of Calquence plus chemoimmunotherapy for first-line mantle cell lymphoma

CHMP recommends approval for Tevimbra as a first-line treatment for extensive-stage small cell lung cancer

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