FDA Fast-Track Shutdown Raises Approval-Timeline Risks for Biotech Investors
The reported end of the FDA Fast-Track program could lengthen approval timelines, while SPY valuation reportedly remained steady.
Biotech Traders Face a Year-End Wave of FDA Catalysts for BBIO and VRTX
Priority reviews for BBIO and VRTX create a concentrated late-2026 FDA calendar spanning muscle disease, kidney disease, cancer, pain and epilepsy.
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CanaRx Arrests Put Cross-Border Prescription Drug Importation Under the Microscope
The arrests of two CanaRx officials sharpen questions about U.S.-Canada drug trade, discount pricing models and regulato…
ImmunityBio Stock Faces a Sentiment Test as Anktiva Catalysts Collide With a Sharp Weekly Selloff
IBRX is on pace for its worst week in nearly two years even as Anktiva gains a broader approval and a year-end FDA filin…
FDA Fast-Track Program Ends as Biotech Approval Calendar Enters a High-Risk Stretch
The FDA’s Fast-Track decision adds uncertainty to biotech timelines as priority reviews and target dates crowd the calen…
Mirum Pharmaceuticals Keeps Buy Rating After Positive Trial Data
H.C. Wainwright reiterated its Buy rating on $MIRM after positive trial data, keeping attention on Mirum’s rare-disease …
Celcuity’s REVTORPYK Launch Builds Momentum as Competition and Regulation Loom
Celcuity says REVTORPYK is off to a strong early start, but regulatory complexity, competition and infrastructure needs …
Alvotech Enters Pivotal Quarter With Three FDA Biosimilar Decisions Ahead
Alvotech faces three anticipated FDA decisions in the fourth quarter, creating a pivotal test for its commercial outlook…
Wall Street Slides as Inflation Data Revives 50-Basis-Point Fed Hike Fears
Hotter inflation and a hawkish Federal Reserve reset rate expectations, while sharply higher mortgage rates added pressu…
Capricor Therapeutics Shares Rise Ahead of Nov. 22 FDA Decision
CAPR shares are drawing speculative interest ahead of the FDA’s Nov. 22 decision, creating a binary catalyst for traders…
Gossamer Bio Price Target Cut as Analysts Diverge on NDA Outlook
Wedbush lowered its Gossamer Bio price target over regulatory uncertainty, while H.C. Wainwright and Chardan remain bull…