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Regulatory Affairs

FDA Approvals FDA FDA Approval Drug Approval Process Drug Approval Biologics License Application FDA Designations Drug Legislation Compliance Enterprise Value

Biofrontera Reports Record 2025 Revenue of $41.7 Million and Best-Ever Q4 at $17.1 Million

Management attributed the outperformance to broader adoption of its Ameluz photodynamic therapy.

Tenon Medical Posts Record 2025 Revenue as SImmetry+ Wins FDA Clearance

EU Grants Conditional Approval for ImmunityBio’s Anktiva in BCG‑Unresponsive Bladder Cancer

Medtronic Tops Q3 Estimates, Reaffirms Outlook on PFA-Fueled Cardiovascular Surge

USFDA Accepts Wockhardt’s NDA for Novel Antibiotic Zaynich as Stock Rallies

Day One to Acquire Mersana in Backloaded Deal Worth Up to $285 Million

Novartis Opens Carlsbad Radioligand Therapy Plant as U.S. Buildout Accelerates

Eli Lilly Unveils $3 Billion Netherlands Plant to Scale Production of Oral Weight‑Loss Pill

Regeneron Tops Q3 Forecasts on Dupixent Strength as Eylea HD Faces FDA Delay

Medpace Jumps as Q3 Tops Forecasts, Bookings Surge and Outlook Rises

Senseonics to Reclaim Eversense 365 Commercialization From Ascensia in 2026

Merck Announces €3 Billion Acquisition of Springworks Therapeutics

Viking Therapeutics Advances Weight-Loss Drug, Shaking Up Market Leaders