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AbbVie and Genmab announced positive topline results from the P-III (EPCORE DLBCL-2) study, demonstrating a statistically significant and clinically meaningful improvement in PFS vs R-CHOP alone (SoC) in newly diagnosed diffuse large B-cell lymphoma (DLBCL) pts. with an IPI score of 2-5
The study evaluated fixed treatment duration epcoritamab(SC) plus rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and…
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FDA approval was based on the P-III (TEMPO) program, which evaluated Juvmo in early PD pts not taking oral levodopa (TEMPO-1 & 2) & as an adjunct to oral levodopa vs PBO + levodopa in PD pts with motor fluctuations (TEMPO-3)
At Wk. 26 in TEMPO-1, Juvmo showed MDS-UPDRS Part II scores of −1.6…
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AbbVie has reported the P-III (CERVINO) trial assessing etentamig (Q4W) vs standard available therapies in pts with R/R MM who have received ≥2 prior lines of therapy, incl. exposure to a proteasome inhibitor, an immunomodulatory drug & an anti-CD38 mAb
At the mFU of 11.4mos. (n=393 pts; median 3 prior lines), trial met its dual 1EPs…
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The EMA has received an application seeking approval for Skyrizi (risankizumab; SC induction) for the treatment of adults with moderately to severely active Crohn's disease (CD)
Application was backed by the P-III (AFFIRM) trial assessing Skyrizi (SC) as an induction treatment in above-mentioned pts (n=289) in 3 periods: Period A compared Skyrizi against PBO for 12wks., blinded…
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The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca.
EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…
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The US FDA has accepted sBLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked MMP associated with masseter muscle activity in adults
sBLA was supported by 2 P-III (M21-416 and M21-417) studies, both of which met their 1EPs & showed improvements in the severity of MMP vs…
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Merck & Co., Roche, and Johnson & Johnson emerged as the leading pharmaceutical companies by R&D expenditure in 2025, investing $15.78B, $15.49B, and $14.66B, respectively. Continued investments in late-stage clinical programs, pipeline expansion, advanced technologies, and strategic business development reinforced their commitment to driving pharmaceutical innovation
Global biopharmaceutical R&D investment continues to accelerate as…
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The EC has approved Rinvoq (upadacitinib; 15mg, QD) for the treatment of pts (≥12yrs.) with non-segmental vitiligo (NSV) who are candidates for systemic therapy
Approval was backed by the Viti-Up clinical program (M19-044; n=614), incl. 2 replicate trials assessing Rinvoq, where in Period A, pts were randomized to either Rinvoq or PBO for 48wks. &…
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AbbVie led the global immunology market with $30.4B in immunology revenue in 2025, followed by Sanofi ($19.08B) and Johnson & Johnson ($15.72B). Continued demand for biologics and targeted therapies across autoimmune and inflammatory diseases supported strong commercial performance among leading companies.
The global immunology market, valued at $108.4B in 2024, is projected to…
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The EC has approved Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (Tepkinly + R2) for the treatment of adults with R/R follicular lymphoma (FL)
Approval was based on the P-III (EPCORE FL-1) trial assessing fixed-duration Tepkinly + R2 (n=243) vs SoC R2 (n=245) in pts with R/R FL following ≥1 prior line of treatment
Trial…

