Pharma company granted FDA clearance for alopecia drug study
The goal is to find a cure for alopecia areata, an autoimmune disease that causes hair loss in distinct round patches.
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FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
Wong, Founder and CEO of HCW Biologics, commented, “The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative ...
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MHRA seeks input on new regulatory guidance for cancer vaccines
The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
FDA approves HCW Biologics trial for alopecia treatment
MIRAMAR, Fla. - HCW Biologics Inc. (NASDAQ: HCWB), a clinical-stage biopharmaceutical company with a market capitalization of approximately $12.4 million, announced today that it has received U.S.
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FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...