The treatment, being evaluated for severe asthma, is the first ultra-long-acting biologic to be evaluated in Phase III trials. Results from GSK’s two Phase III clinical trials evaluating the biologic depemokimab has shown promise in extending dosing intervals in severe asthma, with individuals just requiring two doses annually.
U.S. Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. Patients should stop taking Veozah immediately and seek medical attention, including liver blood testing, if they experience signs and symptoms that suggest liver problems such …
FDA revised the final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” This guidance describes how the assessment goals under the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) …
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FDA published additional resources for the 2023 Proposed Rule on Medication Guides: Patient Medication Information (PMI), as part of its Guidance Snapshot Pilot Program. The resources include patient and industry focused snapshots, recap podcasts, and podcast transcripts about the proposed rule. This is the first time the program is expanding beyond providing additional resources for guidance documents.
On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS).
On August 8, 2024, FDA announced the availability of a final guidance for industry entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases, replacing the January 2023 draft guidance on this topic. This final guidance describes the FDA recommendations for identifying an optimized dosage(s) for human prescription drugs …
