Top FDA Approvals to Watch in H2 2026: Regulatory Decisions Poised to Transform the Pharmaceutical Landscape
Promising candidates that are expected to launch in H2 2026 include Celcuity's gedatolisib, Replimune's vusolimogene oderparepvec (RP1), Merck's subcutaneous KEYTRUDA, Gilead Sciences' bictegravir plus lenacapavir, Lantheus' MK-6240, Nuvalent's zidesamtinib, Novo Nordisk's denecimig (Mim8), Savara's MOLBREEVI, and BioMarin's BMN 351.
POLYTECH Announced Regulatory Clearance for Improvements to the Microthane Process; ElectroWire Medical Earns 510(k) Clearance for LightningWire™ System; NeuroLexIQ Partners with Canary Speech to Introduce AI-Driven Voice Analysis for Injury Intake; BIOTRONIK Neuro Acquires Spinal Cord Stimulation Technology from Soin Neuroscience; Lakewood-Amedex Biotherapeutics Highlights Preclinical Safety Evidence Ahead of Nu-3 Gel Phase 2a Study; Cumulus Neuroscience Presents Evidence That Two-Minute Digital Test Enhances Alzheimer’s Trial Pre-enrichment
Notizia - Recent Pharma, Healthcare and Biotech Happenings
Jul 16, 2026
The Rise of Targeted Therapeutics in Modern Healthcare
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Jul 15, 2026
Hengrui Pharma Encounters FDA Regulatory Hurdle for Camrelizumab–Rivoceranib; Kailera Therapeutics Announces Positive Results for HRS-7535/KAI-7535 Across Two Phase 3 Studies; Jemperli Underscores Durable Clinical Complete Responses in dMMR/MSI-H Rectal Cancer; FDA Approves PADCEV-Keytruda Combination for Neoadjuvant and Adjuvant Treatment of Muscle-Invasive Bladder Cancer; Sanofi’s Subcutaneous Sarclisa Escena Gains US Approval
Notizia - Recent Pharma, Healthcare and Biotech Happenings
Jul 14, 2026
Monoclonal Antibodies Fueling the Next Wave of Growth in the Interstitial Lung Disease Treatment
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Jul 13, 2026
Top Obesity Drugs by Revenue in 2025: The Biggest Winners in the Weight Loss Market
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Jul 10, 2026
The Next Wave of Radioligand Therapies: 5 Candidates to Watch
Mar 20, 2026
Emerging TIL Therapies Poised to Broaden the Landscape Beyond AMTAGVI
Mar 06, 2026
Newsletter/Whitepaper
Currently, there are no FDA-approved treatments for acute concussion. The current standard of care is rest, followed by a gradual return to normal activity. Off-label therapies are used to manage TBI. In July 2024, the first cell therapy, AKUUGO, was approved in Japan for improving chronic motor paralysis resulting from TBI. It obtained conditional and time-limited marketing approval, which was further granted full approval in October 2025. The company is planning to launch AKUUGO in the Japanese market in 2026.
A mid pharma client based in Germany, involved in late-stage development of a therapy for PID, with effective marketing and commercialisation presence in Europe, wanted to assess the launch readiness of competitors involved in the same arena for strategic positioning of their product. They wished to identify and evaluate the launch timelines, geographies of launch, First Launch company, commercial readiness, and salesforce of competitors.
A large pharma client was working to develop their cyclophosphamide API and FD and was interested to assess competitive products in the same domain and area to provide benchmarking of their asset in comparison to their competitors The client requested periodic reports (Quarterly) on the developmental milestones of competitor companies, thorough assessment of the competitor products through Secondary and Primary CI inputs.
A mid-sized pharma client was working to develop their asset portfolio and was interested in assessing best possible asset for atrial fibrillation for future development and licensing needs. The client requested evidence-based priorities in assets and products for Phase II development in atrial fibrillation, through potential licensing collaborations. Also, the client wanted to prioritise research efforts to determine the best possible asset to leverage their research portfolio.
A small pharmaceutical client based at Sweden, Europe with capabilities around a neonatal mesenchymal cells involved DelveInsight to identify a licensing partner for their stem cells product, from across the globe. They wished to identify a potential list of companies, to become a fit for their neonatal high quality MSCs and can prove to be a good business partner as a licensee for their proprietary “API” of the stem cell therapy domain.
A large client based in the USA, involved in drug delivery devices, with effective marketing and commercialisation presence across the globe, wanted to in-license potential dMTS based drug delivery asset from companies involved in microneedle technology research for delivering therapeutic products. They wished to identify and assess the technological competencies, clinical capabilities and commercial readiness of potential companies with a novel and non-invasive way of delivering drugs, which can include a variety of drugs/vaccines in their patch and successfully develop the product for commercial purposes, were of client’s interest.
A medium pharmaceutical client based in the United States with biosimilar commercial capabilities involved DelveInsight to identify commercial processes and strategies to launch their biosimilar in Europe through Competitive Assessment of their EU based competitors in the same area of interest. They wished to identify manufacturing sites, logistic operations, distribution network, salesforce assessment and their sales targets.