FDA’s Rasonque Approval Opens a New RAS-Targeted Option in Metastatic Pancreatic Cancer
FDA has approved Rasonque, or daraxonrasib, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic…
FDA’s Ziihera Approval Creates a New First-Line HER2-Positive GEA Decision Tree
FDA has approved two zanidatamab-hrii, or Ziihera, treatment approaches for adults with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal-junction…
Capricor’s PDUFA Extension Makes the Endpoint Case Central to Deramiocel’s Review
Capricor Therapeutics announced on August 24 that FDA extended the target action date for its Biologics License Application for deramiocel,…
Genglycos Brings the First Approved Therapy to GSDIa—But Its Accelerated Approval Is Only the Beginning
The FDA’s accelerated approval of Genglycos is a landmark for patients with glycogen storage disease type Ia, a rare inherited…
FDA Feedback Gives Oncolytics a Potential Shortcut—But REO 033 Still Must Earn Its Pivotal Expansion
Oncolytics Biotech has secured FDA written feedback that could make the development path for pelareorep in metastatic colorectal cancer more…
Argenx’s ALKIVIA Result Opens a New Therapeutic Front in Autoimmune Myositis
Argenx has reported positive Phase 3 results for VYVGART Hytrulo in autoimmune myositis, a heterogeneous group of rare inflammatory diseases…
How BioLayer is Rewriting the Data Supply Chain for Healthcare AI
As consumer health agents and biomedical AI models accelerate, the central economic and ethical question facing the industry is no…
AbelZeta’s Prizlon-cel IND Reopens the Question of How CAR-T Can Work After CAR-T Failure
AbelZeta Pharma has received FDA clearance to begin U.S. clinical development of Prizlon-cel, an anti-CD20/CD19 bispecific CAR-T therapy for relapsed…
Zenbexus Opens a New Myeloma Drug Class, but the Confirmatory Test Still Lies Ahead
The FDA’s accelerated approval of Bristol Myers Squibb’s Zenbexus gives multiple-myeloma treatment a new class of medicine and creates an…
Xilio’s New IND Tests Whether Masked IL-2 Can Make Immunotherapy Safer in Solid Tumors
The U.S. Food and Drug Administration has cleared Xilio Therapeutics to begin human testing of XTX501, a bispecific PD-1 and…
Manufacturing Stumble: FDA Rejects ITM Radiopharma’s Neuroendocrine Tumor Therapy
In a stark reminder of the immense logistical complexities surrounding radiopharmaceuticals, the U.S. Food and Drug Administration (FDA) has issued…