Navigating Drug Development: The Critical Role of Performing Solid Form and Physicochemical Studies in Parallel
Worldwide Clinical Trials – USA: Senior Director, Business Development, BioAnalytics REMOTE EAST COAST
FDA Appears to Be Granting Zombie Rare Pediatric Disease Designations Waiting for the Rare Pediatric Disease Priority Review Voucher Program to be Revived
Get Up To Speed on Medicare Inflation Rebates: HPM Issues Memorandum Summarizing CMS Final Rule; HPM and Riparian to Co-Host Webinar
Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft
DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution
Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia
Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura
Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
LIB Therapeutics Submits a Biologics License Application to FDA for Lerodalcibep for the Treatment of Adults with Elevated LDL-Cholesterol
Crinetics Announces FDA Acceptance of New Drug Application for Paltusotine for Adult Patients with Acromegaly
Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia
Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease During their First RSV Season
U.S. Food and Drug Administration Issues Complete Response Letter for the Glepaglutide New Drug Application for the Treatment of Short Bowel Syndrome
PTC Therapeutics Announces Vatiquinone NDA Submission to FDA for the Treatment of Children and Adults Living with Friedreich Ataxia
