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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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INSIGHTS+

Key Biosimilars Events of February 2026 

Shots:  Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.  Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
March 3, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2025   

Shots:  Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact.  In December 2025, the EMA…
January 20, 2026

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VIEWPOINTS

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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EVENTS

Post Conference Highlights: Peptides & Complex Generics Symposium 2025

Day 1 Breakdown The #PCG2025 Symposium commenced on an inspiring note, setting the stage for two days of insightful discussions, collaborations, and knowledge exchange. Opening Session Dr. Ratnesh Jain, Founder & Director, Mumbai Cluster, delivered the inaugural address, sharing his vision of bringing together pharma professionals, R&D experts, CXOs, and academicians to accelerate advancements in…
September 29, 2025

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VIEWPOINTS_Jane Reed_2023
VIEWPOINTS

Jane Reed Highlights the Growing Dependence of NLP to Comply with the Regulatory Guidelines

Shots:  In an invigorating conversation with PharmaShots, Jane Reed discusses the transition from document-driven to data-driven decision-making in the pharmaceutical industry   Jane sheds light on the increasing dependence on AI and ML in regulatory affairs and how it helps pharma companies mitigate errors, discrepancies, and non-compliance   Jane highlights the benefits of NLP in ensuring regulatory…
November 16, 2023

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