Tagrisso (osimertinib) has received Breakthrough Therapy Designation from FDA for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent.
Piqray (alpelisib) received approval from the European Commission in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
FDA has accepted Karyopharm Therapeutics Inc.'s supplemental New Drug Application seeking approval for Xpovio—its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with multiple myeloma after at least one prior line of therapy.
NCI's Cancer Therapy Evaluation Program and Karyopharm Therapeutics Inc. have entered into a Cooperative Research and Development Agreement.
FDA has issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” which describes the FDA's current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.
FDA has published the proposed new rule, Annual Summary Reporting Requirements under the Right to Try Act, that, when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act. jQuery(document).ready(function(){ jQuery('.people-thumb... […]
Two out of four investigational vaccine candidates by Pfizer Inc. and BioNTech SE received Fast Track designation from FDA.
Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostic Services Program, has awarded coverage to the cancer profiling test GEM ExTra.
Inqovi (decitabine and cedazuridine) has received approval for at-home treatment of adult patients with myelodysplastic syndromes and chronic myelomonocytic leukemia.
FDA has accepted and granted priority review for a new supplemental Biologics License Application for Keytruda as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.
