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INSIGHTS+

The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
June 9, 2026

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INSIGHTS+

Key Biosimilars Events of May 2026 

Shots:  May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.  Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.  Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…
June 2, 2026

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VIEWPOINTS

Advancing HES Care with AstraZeneca’s FASENRA: Insights from James Teague & Princess U. Ogbogu

Shots:  Could a targeted biologic therapy help address the longstanding unmet needs in hypereosinophilic syndrome (HES)? AstraZeneca’s FASENRA has now received US approval for HES, introducing a once-monthly treatment option for patients living with this rare and often underdiagnosed eosinophilic disorder  Results from the Phase III NATRON trial showed that FASENRA reduced the risk of first HES flare by 65% vs placebo,…
June 1, 2026

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EVENTS

Evolution Summit 2026 | Sep 28-29 | Park Hyatt Aviara Resort, San Diego, CA

The Evolution Summit returns September 28-29, 2026 at Park Hyatt Aviara Resort, Golf Club & Spa, San Diego, CA, bringing together leading clinical trial executives with innovative suppliers and solution providers in an invitation-only, premium setting.  Expect visionary keynotes, real-world case studies, and interactive forums aligned to the most pressing challenges in clinical operations and…
May 26, 2026

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MAGAZINE

PharmaShots Magazine-May-2026 Edition

Shots: PharmaShots’ May Edition explores how AI is transforming commercial strategies across the healthcare ecosystem by enabling predictive analytics, personalized engagement, dynamic launch planning, and real-time omnichannel optimization while balancing compliance and measurable ROI. The magazine highlights key industry movements shaping global biopharma, including AI-driven drug discovery collaborations, strategic M&A activity, advancements in cell and…
May 14, 2026

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EVENTS

2026 HLTH Europe | June 15-18 | Amsterdam

HLTH Europe is the continent’s #1 healthcare innovation event. Following an enormously successful launch and the exponential growth of HLTH in the US, this landmark event is where global expertise meets local insight to address Europe’s unique healthcare challenges and opportunities. Unlock an exclusive €250 discount with PharmaShots! Use code HE26PHARMASHOTS at checkout to save…
May 14, 2026

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INSIGHTS+

The US FDA New Drug Approvals in April 2026 

Shots:  Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.  Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…
May 12, 2026

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THOUGHTSPOT

CEAS Collective: Bridging Biotech Innovation and Consumer Wellness Through Direct-to-Patient Delivery 

Biotech innovation is rapidly transforming the boundaries of modern wellness, and CEAS  Collective stands at the forefront of this shift. By integrating advanced product  development with a direct-to-patient delivery model, CEAS Collective bridges the gap  between next-generation health solutions and consumer-centric care. Their approach  sets a new benchmark for accessible, holistic wellness, offering patients seamless  access to science-driven products…
May 11, 2026

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VIEWPOINTS

Ending Prescription Ping-Pong in Specialty Care: Colin Banas, CMO, Timely By DrFirst Shares His Vision  

Shots:  Specialty medication access remains challenged by high costs, fragmented workflows, complex prior authorization requirements, and limited transparency, leading to delays, prescription drop-offs, and suboptimal patient outcomes.  DrFirst is addressing these gaps through AI-powered, workflow-integrated solutions that enable real-time benefits verification, targeted prior authorization automation, and smarter pharmacy routing, shifting care from reactive problem-solving to proactive, frictionless prescribing.  PharmaShots welcomes…
May 4, 2026

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