BridgeBio’s PROPEL 3 Update Broadens the Infigratinib Story Beyond Height. The New Results Remain Exploratory.
BridgeBio has reported new exploratory analyses from PROPEL 3, its Phase 3 study of oral infigratinib in children with achondroplasia.…
Leyden Labs’ RIG-101 Clears an Early Safety and Biomarker Hurdle. Phase 2 Must Now Show Clinical Protection.
Leyden Laboratories has reported positive Phase 1 findings for RIG-101, an investigational intranasal innate-immune modulator intended to strengthen antiviral defenses…
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…
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…
Ultragenyx’s Aspire Readout Shows Why Phase 3 Evidence Still Decides Rare-Disease Programs
Ultragenyx has reported that its Phase 3 Aspire study of apazunersen, also called GTX-102, in Angelman syndrome did not meet…
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…
Lisraya Gives Dermatomyositis Its First FDA-Approved Oral Treatment Option
FDA has approved Lisraya, or brepocitinib, tablets for adults with dermatomyositis, creating the first FDA-approved oral treatment option for this…
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…