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FDA issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in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.
FDA approved Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
On Sept. 24, 2002, when I showed up at a meeting of the FDA Oncologic Drugs Advisory Committee, I had a pretty good idea that the drug on the agenda—AstraZeneca’s Iressa (gefitinib)—was having a surprising effect on some patients in third-line non-small cell lung cancer.
FDA approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
Zymeworks Inc., a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, announced that FDA has cleared the investigational new drug application for ZW171, a novel 2+1 T-cell targeting bispecific antibody for mesothelin-expressing cancers.
FDA approved lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
FDA granted accelerated approval to repotrectinib (Augtyro) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.
