Research & Development
Policy & Regulation
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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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