FDA Tightens Accelerated Approval Timelines Under New FDORA Authorities
Regulators are requiring confirmatory Phase 3 trials to be actively enrolling before granting accelerated approval, eliminating years of post-market clinical uncertainty.
Section
Pipeline
Trials, approvals, and the drugs behind them.
BridgeBio's Acoramidis Review Extension Delays Commercial Clash with Tafamidis
A major amendment to chemistry and manufacturing controls prompted a three-month FDA review extension, giving Pfizer additional runway in ATTR cardiomyopathy.
In Vivo CAR-T Reaches First Clinical Proof-of-Concept in Lymphoma
Targeted lipid nanoparticles reprogramming circulating T cells inside the body achieved complete metabolic responses, bypassing complex ex vivo manufacturing logistics.
Alnylam's HELIOS-B Data Challenges Oral Stabilizers in ATTR Cardiomyopathy
Phase 3 vutrisiran data demonstrated a 28% reduction in mortality risk, setting up an upstream gene-silencing showdown against Pfizer's incumbent oral blockbuster tafamidis.
Biopharma Venture Capital Mega-Rounds Consolidate Around De-Risked Clinical Assets
Venture syndicates are concentrating capital into $100M+ Series A and B rounds for clinical-stage assets, leaving early-stage discovery platforms to navigate lean seed environments.