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The US FDA approved three notable therapies in June 2026, spanning diagnostic imaging, infectious diseases, and ophthalmology, highlighting continued progress in precision diagnostics, antimicrobial innovation, and rare disease treatment.
Key approvals included Ambelvist (enhanced MRI detection of lesions), Utebzi (complicated urinary tract infections, including pyelonephritis), and Lumvoa (thyroid eye disease), expanding treatment and diagnostic options for patients with diverse clinical…
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PharmaShots' latest report chronicles the transformation of the global biopharma industry from 2006–2025, highlighting how innovation, strategic M&A, AI adoption, and evolving commercialization strategies have reshaped the competitive landscape while companies navigated patent cliffs, pricing pressures, and shifting market dynamics.
The report tracks the rise and fall of leading biopharma companies over two decades driven by…
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This edition explores AI-Powered Pharmaceutical Logistics, highlighting how artificial intelligence, predictive analytics, robotics, IoT, and digital twins are transforming pharmaceutical supply chains into intelligent, resilient, and patient-centric networks that optimize forecasting, manufacturing, warehousing, and global distribution.
Through expert perspectives, feature stories, and regulatory insights, we examine the opportunities and challenges of AI-enabled pharmaceutical logistics—from…
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June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC), and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology, ophthalmology, oncology, osteoporosis, and reproductive medicine.
Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.
Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.
Celltrion Seeks…
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Breztri Aerosphere became the first and only fixed-dose triple-combination maintenance therapy approved in the US for asthma patients aged 12 years and older, expanding beyond COPD and reinforcing the role of single-inhaler triple therapy in advancing asthma care.
The approval strengthens AstraZeneca’s respiratory portfolio and long-term vision of transforming care beyond symptom control, with additional regulatory reviews…
What does it really take for a biotech company to become an attractive acquisition target?
In this episode of PharmaShots CXO Talks, Jared Kelly, CEO & Director of Oncolytics Biotech, shares an insider's perspective shaped by years of experience in biotech transactions, corporate strategy, and business development.
Before joining Oncolytics, Kelly served as Head of…
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The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.
CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…
AI has moved beyond proof-of-concept on the clinical side of pharma, driving rapid discovery of new molecules. But post-market commercialization teams tell a different story: their boards are asking them to use AI to solve the problems caused by multiple rounds of layoffs, mounting pressure to do more with less, and a human capital fabric…
Get ready to connect with the innovators, investors, and industry leaders shaping the future of biotechnology at the London Biotechnology Show 2026. Taking place alongside London Life Sciences Week, the event is set to become one of the UK’s most influential gatherings for the global biotech and life sciences ecosystem.
Bringing together 4,000+ attendees and…
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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,…

