severe hypertriglyceridemia treatment
Ionis Tryngolza Wins FDA Approval, Expands to 3.6 Million Patients
Ionis Pharmaceuticals submitted a label expansion and the FDA said yes. Replimune has now been rejected twice on the same melanoma drug and just got the FDA to accept a third attempt, this time with an advisory committee meeting attached. One company is celebrating a smooth approval. The other is celebrating an agency that will…
What the FDA’s Mixed Regulatory Signals in 2026 Mean for Smaller Biotechs
The FDA did not produce a landmark approval this week. What it produced was something arguably more useful for investors watching the sector: a clear picture of where the regulatory environment is heading and what that means for the companies positioned inside it. A June 30 PDUFA date for a second major indication from one…
