BioPharma Dive1d
First Prader-Willi drug to reduce hunger approved by FDA
Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.
Soleno Therapeutics execs reap stock windfall after FDA approves rare disease drug
Soleno Therapeutics' FDA-approved drug for Prader Willi Syndrome triggers executive stock bonuses as the company's value ...
Healio12h
FDA recap: First new treatment for stroke in 3 decades, generic rivaroxaban and more
The FDA recently approved the first treatment in nearly 30 years for acute stroke, and the agency also approved a novel drug ...
The New York Sun8dOpinion
Federal Drug Regulators Threaten America’s Innovative Pharmaceutical Industry
Somehow Washington regards the industry, which has saved and improved tens of millions of lives, as a villain.
BioPharma Dive1d
Wave to seek approval of Duchenne drug after mid-stage study data
The company plans to file next year for an accelerated clearance of its "exon-skipping" treatment, which would compete with one of Sarepta's medicines.
Soleno Therapeutics Announces U.S. FDA Approval of VYKATTM XR to Treat Hyperphagia in Prader-Willi Syndrome
First approved therapy to address hyperphagia in individuals with Prader-Willi syndromeManagement to host conference call and webcast today, ...
Sungen Biomedical's world-first new drug SGC001 monoclonal antibody receives FDA fast track approval
US time, the world's first acute myocardial infarction (AMI) antibody drug, SGC001, developed by Sungen Biomedical—an innovative biopharmaceutical company incubated by Beijing Hotgen Biotech Co., Ltd.