Policy and Regulation

FDA issues safety warning for risk of T-cell malignancies with CAR T-cell therapies

The FDA issued a safety warning that patients who have received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies may be at higher risk of developing new T-cell malignancies, including CAR-positive lymphoma.

November 30, 2023

KSQ Therapeutics receives FDA clearance for trial of CRISPR-Cas9 engineered tumor therapy

Biotech firm KSQ Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a phase I and II trial of KSQ-001EX, KSQ’s CRISPR-Cas9 engineered tumor-infiltrating lymphocyte program.

November 29, 2023

AMP, other stakeholders urge Congress to pause FDA LDT rule, update CLIA

The Association for Molecular Pathology (AMP) requested Congress to update the Clinical Laboratory Improvement Amendments (CLIA) as an alternative to the FDA’s proposed rule to increase agency oversight of laboratory-developed tests (LDTs).

November 22, 2023

U.K. regulators approve "world-first" sickle-cell gene therapy

U.K. medical regulators have approved a “world-first” gene therapy that aims to cure two blood disorders: sickle cell disease and transfusion-dependent β-thalassemia. They are the first regulatory body to approve the treatment.

November 20, 2023

FDA plans to increase oversight of LDTs garner strong response

Plans to increase U.S. Food and Drug Administration (FDA) oversight of laboratory-developed tests (LDTs) have drawn a strong response from trade groups, individuals, and organizations.

November 17, 2023

Zymo Research, Ad Astra Diagnostics receive FDA 510(k) clearances

Molecular diagnostics firm Zymo Research and rapid diagnostics developer Ad Astra Diagnostics have both received 510(k) clearances from the U.S. Food and Drug Administration.

November 16, 2023

FDA grants approval to Takeda’s metastatic colorectal cancer therapy

The U.S. Food and Drug Administration (FDA) has approved a chemotherapy-free oral target therapy for patients who have been previously treated for metastatic colorectal cancer (mCRC).

November 9, 2023

Vertex Pharmaceuticals, CRISPR Therapeutics gene-editing therapy to undergo FDA advisory committee review

An FDA advisory committee is scheduled to meet on October 31 to discuss and make recommendations on Vertex Pharmaceuticals' and CRISPR Therapeutics’ CRISPR-Cas9 gene-editing-based therapy, exagamglogene autotemcel.

October 30, 2023

FDA to discuss phaseout enforcement discretion for LDTs

In relation to its proposed medical device rule targeting laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) will hold a webinar Tuesday, October 31, at 1 p.m. EST.

October 26, 2023

3EO Health to launch FDA-approved COVID-19 test

Molecular diagnostics startup 3EO Health is preparing to launch a newly approved SARS-CoV-2 test with its portable molecular device, saying it will “expand access” to the technology.

October 20, 2023

BioMérieux receives CE Mark for biomarker assay for mild TBI

BioMérieux has obtained the CE Mark for its assay to detect two biomarkers associated with mild traumatic brain injury (mTBI).

October 16, 2023

European Commission orders Illumina to sell Grail

Illumina has been ordered by the European Commission to sell Grail following the European Union antitrust regulatory body’s determination to prohibit the $8 billion acquisition of the company.

October 12, 2023

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