Regulatory Updates

Personalized mRNA Cancer Vaccines: A New Era for Melanoma Treatment

melanoma · 7 min

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

FDA · 10 min

Navigating the Regulatory Landscape: A Strategic Policy Agenda for Private Equity in Healthcare

8 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

Elite Pharmaceuticals Announces Filing of Abbreviated New Drug Application with the U.S. Food and Drug Administration for Generic Anticoagulant Product

U.S. Food and Drug Administration · 10 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

FDA Expands ENDS Market Access: Implications for Pharma BD and Investors

FDA · 8 min

Amgen and Zai Lab Leadership Shifts: Strategic Implications for Pharma BD and Investors

FDA · neurology · 8 min

FDA Approves Atezolizumab for ctDNA MRD-Positive MIBC: A New Era for Adjuvant Therapy

FDA · muscle invasive bladder cancer · 7 min