FDA issued a revised draft guidance for industry, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to frequently asked questions about FDA’s processes, policies, and regulation regarding charging patients for investigational new drugs under certain circumstances in clinical trials or expanded access for treatment use.
FDA accepted for review a Biologics License Application from ImmunityBio, Inc. for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
FDA has granted Fast Track designation for the development program of eltanexor as monotherapy for the treatment of patients with relapsed or refractory intermediate, high-, or very high-risk myelodysplastic syndromes (MDS).
FDA accepted the Biologics License Application and granted priority review for mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
FDA approved Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR T-cell therapy, for the treatment of adult patients with large B-cell lymphoma
FDA issued a draft guidance, “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.”
FDA has granted accelerated approval to Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
FDA granted Fast Track designation for IK-930, a novel TEAD inhibitor targeting the Hippo signaling pathway, in patients with unresectable NF2-deficient malignant pleural mesothelioma.
FDA announced it will issue marketing denial orders to all JUUL e-cigarette products. The products must be removed from shelves across the country or risk enforcement action, as FDA has ruled they do not meet the public health standard required to be authorized for sale.
FDA granted Orphan Drug Designation to stage LSD1 inhibitor iadademstat for the treatment of patients with small cell lung cancer.
