The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.
FDA has accepted the filing of Telix Pharmaceuticals Limited’s New Drug Application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.
FDA cleared the investigational new drug application for ZW191, a novel folate receptor-α targeted topoisomerase I inhibitor antibody-drug conjugate sponsored by Zymeworks.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
FDA granted Fast Track designation for 225Ac-FL-020, a radiopharmaceutical which targets prostate-specific membrane antigen for the treatment of metastatic castration-resistant prostate cancer.
The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises.
The Supreme Court struck down the Chevron doctrine, removing one of the foundational principles of administrative law and upending the way federal agencies rely on technical subject-matter expertise. What comes next?
FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC
FDA granted Fast Track designation to Syncromune Inc., a clinical-stage biopharmaceutical company, for SYNC-T SV-102 therapy, Syncromune’s lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer.
Leaders of three health agencies presented new initiatives focused on patient-centered research, diversity in clinical trial enrollment, and innovation in clinical research.
FDA issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting diversity action plans to support certain clinical studies.
