FDA Approves Drug to Treat Chronic, Progressive Lung Disease
The U.S. Food and Drug Administration (FDA) approved Jascayd (nerandomilast) tablets to treat adults with progressive pulmonary fibrosis (PPF).
FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development
FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development
REMS Compliance Program
REMS Compliance Program
Processes and Practices Applicable to Bioresearch Monitoring Inspections
Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry
Avoiding Products Contaminated with Hidden Ingredients
Many products claiming to help with health issues hide dangerous drug ingredients. Get informed about how to avoid contaminated products…
FDA Roundup: August 25, 2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Medication Health Fraud for Specific Diseases and Conditions
FDA has identified condition-specific medication health fraud scams that can pose significant risks to consumers.
FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection
On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous…
Investigations Into the Human Metabolism of Trestolone (7α‐Methyl‐19‐Nortestosterone)
As the known metabolites of 7α-methyl-19-nortestosterone (MENT), M1 and M2, suffer from chromatographic issues under routine doping control conditions, the…