Targeted Oncology2d
FDA Grants 225Ac-SSO110 Orphan Drug Status in SCLC
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
This study will evaluate HCW9302 in patients with moderate to severe alopecia areataMIRAMAR, Fla., Feb. 03, 2025 (GLOBE ...
Business Wire1mon
Epirium Bio Announces FDA Clearance of Investigational New Drug Application for MF-300 and Appointment of Alex Casdin as New Chief Executive Officer and Russell Cox as ...
The U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin ...
Yahoo Finance7d
United Therapeutics Corporation Announces FDA Clearance of its Investigational New Drug Application for the UKidney Xenotransplantation Clinical Trial
today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company’s investigational UKidney ...
precisionmedicineonline3d
FDA Clears Aro Biotherapeutics' siRNA Drug IND for Late-Onset Pompe Disease
The company has already kicked off an open-label Phase I trial of ABX1100 in Canada following positive results from a study of healthy volunteers.
Forbes1y
FDA Report Reveals 300% Increase In Cannabis Research Over The Last Decade—Key Findings
The last decade has seen a “dramatic increase” in investigational new drug (IND) applications for cannabis-derived products, according to the U.S. Food and Drug Administration. In a paper ...
BioSpace13dOpinion
Opinion: Contenders Vie to Challenge BioMarin in Achondroplasia Space
Achondroplasia, which affects around one in 20,000 babies, has just one approved treatment: BioMarin’s Voxzogo. However, new ...
Business Insider1mon
Solid Biosciences's IND For Gene Therapy To Treat Friedreich's Ataxia Gets FDA Clearance
(RTTNews) - Life sciences company Solid Biosciences Inc. (SLDB), Tuesday announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ...
Morningstar7d
United Therapeutics Corporation Announces FDA Clearance of its Investigational New Drug Application for the UKidney Xenotransplantation Clinical Trial
United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application ...