JD Supra2d
FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
Healio6d
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 ...
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.
Targeted Oncology3d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Business Insider6d
HCW Biologics Gets Clearance Form FDA To Initiate Phase 1 Study Of HCW9302 In Alopecia Areata
(RTTNews) - HCW Biologics Inc. (HCWB) a clinical-stage biopharmaceutical company, Monday said that the Food and Drug Administration (FDA)has given clearance to initiate a Phase 1 study of its lead ...
Nasdaq6d
HCW Biologics Inc. Receives FDA Clearance for IND Application to Initiate Phase 1 Clinical Trial of HCW9302 for Alopecia Areata
HCW Biologics Inc. has announced the FDA's approval of its Investigational New Drug Application to begin a Phase 1 clinical trial for HCW9302, a new immunotherapy targeting alopecia areata ...