Rentosertib’s Aging-Clock Study Is a Biomarker Signal, Not Evidence That a Drug Reverses Human Aging
Insilico Medicine has published an analysis of its Phase IIa idiopathic pulmonary fibrosis, or IPF, data in which six proteomic…
Category: Biotechnology
Clover’s Phase 2 Combination-Vaccine Data Are Encouraging. They Are Not Yet an Efficacy Verdict.
Clover Biopharmaceuticals has reported preliminary Phase 2 data for two respiratory combination-vaccine candidates aimed at older adults: SCB-1022, targeting RSV…
FDA’s Zanvastro Approval Creates a First Disease-Targeted Option for Alexander Disease
The U.S. Food and Drug Administration has approved Zanvastro, or zilganersen, for pediatric and adult patients with Alexander disease. The…
Batten-1’s Phase 3 Submission Puts a Rare-Disease Trial Design Under the Microscope
THX Pharma, the Beyond Batten Disease Foundation and Biocodex have submitted regulatory applications to begin Batten-1-02, a Phase 3 study…
BioVie’s Long COVID Trial Completion Moves Bezisterim to the Interpretation Stage
BioVie has completed the last on-treatment visit in its ADDRESS-LC Phase 2 study of bezisterim for neurological symptoms associated with…
COMIRNATY XFG Approval Narrows the Conversation to Variant Match, Eligibility and Delivery
Pfizer and BioNTech say FDA has approved the supplemental biologics license application for a 2026–27 COMIRNATY formulation targeting the XFG…
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,…
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…