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INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2026    

Shots:  The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
March 17, 2026

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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+

2025 EMA Drug Approvals Outlook: A Year of Intentional, Biology Led Medicine Across Europe 

Shots:  EMA approvals in 2025 reinforce a biology-first regulatory standard, favoring mutation-exact, genotype-defined, and severity-weighted therapies that narrow indications, elevate rare diseases, and reward durability of benefit over rapid market expansion  Convenience at the EMA is no longer cosmetic, it is integral to benefit–risk assessment, with oral, subcutaneous, and low-burden dosing strategies increasingly tied to adherence, long-term outcomes,…
January 22, 2026

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INSIGHTS+

The US FDA New Drug Approvals in December 2025 

Shots:  Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precision  Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…
January 13, 2026

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TOP 20

20 AI Healthcare Companies of 2025  

Shots:  AI is revolutionizing healthcare, reshaping drug discovery, protein design, and precision therapeutics. Companies are now tackling previously “undruggable” targets and moving treatments through development pipelines faster than ever  The AI in the healthcare market is exploding. From a valuation of $26.57B in 2024, it is projected to reach $505.59B by 2033, growing at a CAGR of 38.8%. This rapid…
December 18, 2025

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MAGAZINE

PharmaShots Magazine-December-2025 Edition

In a healthcare environment defined by rapid scientific leaps and rising patient expectations, two influential forces are quietly reshaping the industry’s very foundation: Key Opinion Leaders (KOLs) and Patient Advocacy Groups (PAGs) Once background contributors, they have emerged as pivotal architects of modern healthcare, steering clinical decisions, shaping scientific narratives, influencing policy, and ensuring that patient voices are not just heard…
December 11, 2025

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CXO TALKS

CXO Talks: Vikas Sharma Reveals QurAlis’ Bold Vision for the Future of Neuroscience 

In this episode of CXO Talks, PharmaShots speaks with Vikas Sharma, Chief Business Officer at QurAlis, a biotech company leading the development of precision medicines for neurodegenerative diseases  Vikas discusses the company’s FlexASO platform, a next-generation RNA-targeting technology that tackles the root causes of neurological diseases  Vikas also highlights QurAlis’ lead candidates, QRL-201 and QRL-101,…
November 10, 2025

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TOP 20

Top 20 Countries in Health Innovation in 2025 

Shots:  Harnessing in-depth research and data-driven insights, PharmaShots unveils its definitive report on the Top 20 Countries in Healthcare Innovation 2025, a comprehensive guide to the nations setting global benchmarks in healthcare advancement  Through a meticulous blend of quantitative and qualitative analysis, PharmaShots delved into the multifaceted dimensions of healthcare innovation, spotlighting emerging trends such…
November 6, 2025

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