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INSIGHTS+

The US FDA New Drug Approvals in February 2026 

Shots:  Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact.  Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia  Overall, February 2026 reflected…
March 10, 2026

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Bridging Innovation and Clinical Reality: Shalabh Gupta, CEO of Unicycive Therapeutics, on the Future of Biotech

Shots  Cross-industry lessons from technology, design thinking, and startups can reshape drug development by encouraging faster iteration, disciplined decision-making, and a stronger focus on real patient needs, unlocking innovations that traditional biotech models may overlook.    Clinical experience and thoughtful engagement with the U.S. Food and Drug Administration highlight the importance of patient insights, transparent…
March 9, 2026

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Redefining Respiratory Endpoints: Inside Strados Labs’ Vision for Objective, Real-World Lung Monitoring 

Shots:  Clinical trial sponsors are rapidly moving toward objective, continuous respiratory monitoring, adopting technologies like the RESP Biosensor to improve endpoint sensitivity, safety assessments, and real-world patient insight.  Beyond cough frequency, emerging acoustic biomarkers, such as wheezes, crackles, cough intensity, and cough bout patterns, are redefining how respiratory function and therapeutic impact are measured in modern trials.  PharmaShots welcomes Nick Delmonico,…
December 15, 2025

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Breaking New Ground in Oncology: Leonard Mazur from Citius Pharmaceuticals in Conversation with PharmaShots 

Shots:   Citius Pharmaceuticals celebrates its first-ever FDA approval with Lymphir, a novel therapy for relapsed or refractory cutaneous T-cell lymphoma     In an exclusive conversation, Leonard Mazur, Co-Founder and CEO at Citius Pharmaceuticals, shares insights on Lymphir’s launch strategy and its potential impact on the oncology landscape    Leonard also highlights Mino-Lok, Citius’ innovative…
October 6, 2025

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