Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has granted final approval for Indocyanine Green for Injection, USP, 25 mg/vial, with eligibility for 180-day Competitive Generic Therapy (CGT) exclusivity. The approval represents an important milestone for the company, reflecting its continued focus on expanding its portfolio of complex injectable generic medicines while addressing areas with limited generic competition. Under the CGT pathway, the first approved applicant receives a period of market exclusivity following commercial launch, encouraging the development of generic medicines for products with inadequate competition.
Lupin Limited has announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of Sugammadex Injection, reinforcing its presence in the U.S. hospital injectable market. Sugammadex is a selective neuromuscular blockade reversal agent used to rapidly reverse the effects of rocuronium bromide and vecuronium bromide during surgical procedures. The approval follows the company’s earlier tentative approval and enables commercial availability in the United States.
Cipla has achieved a significant milestone with the U.S. Food and Drug Administration (USFDA) granting approval for its Abbreviated New Drug Application (ANDA) for the generic version of Advair Diskus® (fluticasone propionate and salmeterol inhalation powder). The approval covers all three strengths—100/50 mcg, 250/50 mcg, and 500/50 mcg—and allows Cipla to market a therapeutically equivalent alternative to one of the most widely prescribed inhaled combination therapies for asthma and chronic obstructive pulmonary disease (COPD).
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.
