FDA has issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” which describes the FDA's current thinking on several topics relevant to clinical research related to the development of drugs containing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.
Lynparza was approved in the European Union as a monotherapy for the maintenance treatment of adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
Phesgo, a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—has received FDA approval for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer.
Keytruda (pembrolizumab) received FDA approval for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient colorectal cancer.
Bavencio (avelumab) has received FDA approval for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
