The US Food and Drug Administration (FDA) has approved GSK’s JIDEYTRO® (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) whose disease has progressed following prior ROS1 tyrosine kinase inhibitor (TKI) therapy or platinum-based chemotherapy. The approval introduces a next-generation, highly selective ROS1 inhibitor designed to overcome resistance mechanisms associated with earlier-generation ROS1-targeted therapies while maintaining robust central nervous system (CNS) penetration.
Pfizer has announced that the US Food and Drug Administration (FDA) has accepted for Priority Review its supplemental New Drug Application (sNDA) for TALZENNA® (talazoparib), a poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide) for the treatment of adults with metastatic castration-sensitive prostate cancer (mCSPC) harboring homologous recombination repair (HRR) gene alterations. Priority Review designation shortens the FDA review timeline for therapies that may provide significant improvements in the treatment of serious diseases, underscoring the potential clinical importance of this combination in an area of unmet need.
Novo Nordisk has received US regulatory approval for Wegovy® HD (semaglutide 7.2 mg), representing a significant advancement in pharmacological obesity management. This higher-dose formulation of the GLP-1 receptor agonist semaglutide is designed to address unmet needs in patients who do not achieve adequate weight loss with existing therapies. The approval is supported by robust data from the phase 3 STEP UP clinical trial program, which evaluated the efficacy and safety of once-weekly semaglutide 7.2 mg in adults with obesity.
On January 30, 2026, Indoco Remedies Ltd., a Mumbai-based integrated pharmaceutical company, received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Lacosamide Oral Solution USP, 10 mg/mL. This generic formulation is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vimpat Oral Solution 10 mg/mL, originally developed and marketed by UCB, Inc.
On January 23, 2026, OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company focused on therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, announced that the U.S. Food and Drug Administration (FDA) has authorized a single-patient expanded access Investigational New Drug (IND 176297) application—commonly known as compassionate use—for urcosimod (0.05%). The IND was submitted by Pedram Hamrah, MD, at the University of South Florida, to treat a patient suffering from severe NCP who has exhausted available therapeutic options, with no FDA-approved treatments currently existing for this condition.
On January 4, 2026, Ascletis Pharma Inc. (HKEX: 1672), a Hong Kong-listed biotechnology company specializing in metabolic diseases, announced U.S. FDA clearance of its Investigational New Drug (IND) application for a Phase II clinical trial of ASC30 in type 2 diabetes mellitus (T2DM). ASC30 is an in-house discovered oral small molecule glucagon-like peptide-1 receptor (GLP-1R) fully biased agonist, designed for once-daily oral administration or once-monthly to once-quarterly subcutaneous dosing, targeting obesity, diabetes, and related conditions.
