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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,…
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The EC has approved AbbVie's Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed
Approval was supported by the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (60mg, PO) vs PBO as an acute treatment of migraine with or without aura in 1,328 adults (18-75yrs.)
Trial met…
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The US FDA has approved AbbVie's Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with BPDCN
Approval was supported by the global P-I/II (CADENZA) trial in 84 pts with CD123+ hematologic malignancies, incl. BPDCN, where pts received Decnupaz in both frontline (n=33) & relapsed/refractory (R/R) settings (n=51) without active CNS disease
Trial reported a 69.7% composite…
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The CHMP has recommended Boey (trenibotulinumtoxinE) to improve the appearance of mod. to sev. glabellar lines in adults temporarily; decision is expected in the coming mos., & would apply across all 30 EEA states
Opinion was supported by data from 2 P-III trials assessing the efficacy & safety of Boey in adults with…
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Kestrel has entered into a strategic agreement with AbbVie, structured as a warrant deal, granting AbbVie an exclusive option to acquire Kestrel upon achievement of key development milestones
As per the deal, AbbVie will fund development of KST-6051, with an exclusive option to acquire Kestrel based on development & regulatory milestone completion, representing the…
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Biopharma dealmaking in 2025 continued to face significant headwinds, with collaborations frequently collapsing due to strategic reprioritization, fierce competitive pressures, unfavorable clinical readouts, and failure to meet key closing conditions highlighting the inherent uncertainty and capital risk embedded in innovation-driven partnerships
The year underscored a clear dominance of R&D-focused collaborations and licensing agreements,…
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Haisco Pharma entered an exclusive licensing deal with AbbVie, granting later global rights (ex-China, Hong Kong & Macau) to develop, manufacture & commercialize novel pain therapies
As per the deal, Haisco will receive $30M upfront, with the potential to receive up to $715M in development, regulatory, and commercial milestones, along with tiered royalties on future…
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The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …
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2025 pharma M&A was defined by fewer but more transformational deals, with companies prioritizing commercial-stage assets, late-stage pipelines, and platform technologies capable of reshaping long-term growth and strengthening core therapeutic franchises
The year’s momentum was led by three standout transactions, J&J’s $14.6B acquisition of Intra-Cellular Therapies, Novartis’ $12B deal for Avidity Biosciences, and Merck’s…
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AbbVie has reported topline P-III (EPCORE DLBCL-1) trial results assessing epcoritamab vs chemoimmunotherapy (R-GemOx or BR) in 483 adults with r/r DLBCL, who had received ≥1L of therapy (73% had received ≥2L) & were ineligible for HDT-ASCT
Trial showed improved PFS, with improvements across CRR, DoR, & time to next treatment, plus the study did not…

