Business Wire4h
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
FDA accepts Arrowhead's NDA for plozasiran
Arrowhead Pharmaceuticals (NASDAQ:ARWR) said the FDA has accepted its New Drug Application for its drug plozasiran for the ...
Le Lézard16h
Optilume Drug-Coated Balloon Shows Long-Term Efficacy for Urethral Strictures: Five-Year Data Published in the Journal of Urology
Laborie Medical Technologies Corp. (Laborie), a leader in diagnostic and therapeutic medical technologies, has reached a significant milestone with its Optilume® Drug-Coated Balloon (DCB). The ...
APLT INVESTOR DEADLINE: Applied Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Securities Class Action Lawsuit
January 16, 2025) - The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Applied Therapeutics, Inc. (NASDAQ: APLT) securities between January 3, 2024 and December ...
independent.co.ug1d
NDA yet to establish magnitude of problem caused by therapeutic food
The National Drug Authority (NDA) has said that they are yet to determine whether everyone who used Replenish, a ready-to-use ...
JD Supra2d
Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...
Salarius Pharmaceuticals, Inc.: Salarius Pharmaceuticals and Decoy Therapeutics Announce Definitive Merger Agreement
Decoy's proprietary IMP3ACT peptide conjugate drug design and manufacturing platform leverages machine learning (ML) and artificial intelligence (AI) tools Decoy is leveraging non-dilutive funding and ...
JD Supra4d
The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’
The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some ...
Aquestive Therapeutics Provides Business Update and Outlines Key 2025 Objectives
Topical Gel pre-IND meeting and on track to begin Phase 2a clinical trial in alopecia areata in Q2 2025 Unaudited cash and cash equivalents of approximately $70 million as of December 31, 2024 WARREN, ...