Patients with triple-refractory multiple myeloma who are running out of options may soon have a new lifeline. That’s if the FDA follows the unanimous vote of its Oncologic Drugs Advisory Committee (ODAC) and grants accelerated approval to Glaxosmithkline plc’s (GSK) belantamab mafodotin as a fifth-line therapy for adults with relapsed or refractory multiple myeloma.
The U.S. FDA has a number of draft guidances in queue thanks to the COVID-19 pandemic, but released two final guidances in mid-July, including the guidance for clinical investigations for prostate tissue ablation devices. Stakeholders pressed the agency to avoid a fixed period of follow-up for such studies due to variability in the elapsed time for device-related adverse events, but the agency stuck to the draft’s mandate for at least a year of follow-up.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, International Coalition of Medicines Regulatory Authorities.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avicenna.AI, Corneat Vision, Dante Labs, GI Supply, Hd Medical, Qubyx, Revamp Medical, Vela Diagnostics, Vitls, Viveve.
Two weeks after receiving a letter from the FDA citing deficiencies in the NDA seeking approval for VP-102 (cantharidin 0.7% topical solution) in molluscum contagiosum, Verrica Pharmaceuticals Inc. disclosed an unsurprising complete response letter.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Celyad, Deciphera, Fosun, IMV, Inflazome, Janssen, Vanda, Verrica.
Electrocore Inc. has snagged an emergency use authorization (EUA) from the U.S. FDA for use of its Gammacore Sapphire CV noninvasive vagus nerve stimulation (nVNS) to acutely treat asthma exacerbations in known or suspected COVID-19 patients. The hand-held therapy can be used at home and in a health care setting.
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