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PharmaShots Magazine-Aug-2026 Edition

Shots:  This edition explores Tailored Therapy, Smarter Decisions: AI in Personalized Medicine, highlighting how artificial intelligence, machine learning, multi-omics, real-world data, and predictive analytics are transforming personalized medicine into a more precise, data-driven, and patient-centric approach to care, enabling better patient stratification, treatment selection, and clinical decision-making. Through expert perspectives, feature stories, and industry insights,…

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The US FDA New Drug Approvals in July 2026 

Shots:  The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment.   Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…

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A Promise Made at Six: The Winding Road to Cancer Research

An Interview with Priyanka Joshi, Associate Scientist in Analytical Development Introduction Cancer remains one of the world's greatest healthcare challenges, driving scientists to develop more effective and precise treatment approaches. Among the most promising innovations are cell therapies, which harness the body's own immune system to fight cancer. Behind these advances are scientists working to…

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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,…

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EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…

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Amgen

The CHMP Recommends Amgen’s Imdylltra to Treat 1L ES-SCLC   

Shots:  The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT  Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC  Imdylltra is…

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D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…

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Evorpacept’s Momentum in HER2+ Gastric Cancer: A Conversation with Jason Lettmann from ALX Oncology 

Shots:  Evorpacept emerges as the only CD47-blocking therapy with strong clinical activity and a highly manageable safety profile, thanks to its unique inactive Fc design that enables targeted tumor destruction while sparing healthy cells  Updated ASPEN-06 data highlights CD47 overexpression as a powerful predictive biomarker, showing dramatic improvements in ORR, DOR, PFS, and OS for patients with…

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ThoughtSpot_Saurabh Chaubey9

Targeted Therapy in Oncology

Shots:  The oncology domain accounts for more than 50% of ongoing clinical trials. The global oncology drug market was valued at $185B in 2022 and is predicted to reach $205B by 2030 with a 13% CAGR   Targeted therapy targets specific genes and proteins to prevent them from growing and spreading. In 2022, the market size…

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