FDA News

FDA Overhauls Human Factors Guidance: New Submission Category Introduced

FDA · 8 min

Understanding Computer Software Assurance (CSA) and Its Benefits for Pharma

FDA · 7 min

FDA Oncology Draft Guidance: Reducing Animal Testing for Cancer Drugs

FDA · oncology · 8 min

Cumberland Pharmaceuticals (NASDAQ: CPIX) to divest marketed brands to Apotex for $100M

FDA · 10 min

FDA grants orphan status to oxaliplatin for hard-to-treat pancreatic cancer

FDA · pancreatic cancer · 9 min

Gilead Secures First Hepatitis D Drug Approval, Sparking Bay Area Competition

FDA · hepatitis · 9 min

FDA Approves MannKind's Afrezza for Pediatric Diabetes Patients

FDA · diabetes · 7 min

AbbVie's Decnupaz Secures FDA Approval for Rare Blood Cancer

FDA · blastic plasmacytoid dendritic cell neoplasm · 5 min

Eli Lilly's Retatrutide Success Amidst Regulatory Shifts: A Strategic Analysis

FDA · 9 min

Eli Lilly's Strategic Vaccine Acquisitions: A New Era in Infectious Disease

FDA · vaccine · 6 min

Candel's Prostate Cancer Drug: Long-Term Data Insights Ahead of FDA Filing

FDA · prostate cancer · 8 min

White House Taps Amazon, GoodRx to Expand TrumpRx Generic Drug Access

FDA · 7 min