Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

Shots: The US FDA has granted approval to expand the use of Pathway HER2 (4B5) & Ventana HER2 Dual ISH tests to identify HER2+ metastatic gastroesophageal adenocarcinoma (GEA), incl. gastric, GEJ & esophageal adenocarcinoma The companion diagnostics can help identify pts who may be eligible for HER2-targeted treatment with two Ziihera (zanidatamab-hrii) regimens for 1L…

ByRidhi Rastogi3 days ago

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Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…

ByRidhi RastogiAugust 24, 2026

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Nurix Therapeutics Enrolled First Patient in P-III (DAYBreak CLL-306) Trial of Bexobrutideg in R/R CLL/SLL

Shots: Nurix has enrolled the first patient in the global P-III (DAYBreak CLL-306) study assessing bexobrutideg in pts with r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor The trial, conducted under the collaboration between Nurix and Roche, is expected to enroll ~620 pts, where they will be randomized…

ByRidhi RastogiAugust 4, 2026

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Top 20 R&D Spending Biopharma Companies of 2026

Shots: 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…

ByPrince GiriJuly 31, 2026

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Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

Shots: The CHMP has recommended Susvimo (100mg/mL) for the treatment of neovascular age-related macular degeneration (nAMD) The opinion was based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal), where Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to Lucentis (QM, IVT), with Portal showing maintenance of vision up…

ByRidhi RastogiJuly 27, 2026

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Top 20 Immunology Companies of 2026

Shots: 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…

ByPrince GiriJuly 17, 2026

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Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Shots: The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026 Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs…

ByRidhi RastogiJuly 15, 2026

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Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Shots: Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…

ByRidhi RastogiJuly 9, 2026

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Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Shots: Roche has reported the global P-III (Krascendo 1) trial assessing divarasib monotx. (QD) vs sotorasib (QD) or adagrasib (BID) in 338 pts with previously treated KRAS G12C-mutant advanced or metastatic NSCLC The trial met its 1 & key 2EPs, with divarasib achieving improvements in both PFS & OS; data to be submitted to health…

ByRidhi RastogiJuly 2, 2026

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Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Shots: The US FDA has accepted sBLA & granted priority review to Roche's Enspryng (satralizumab; SC) for the treatment of thyroid eye disease (TED), with a decision expected by Oct 15, 2026 sBLA was supported by P-III (SatraGO-1 & SatraGO-2) trials assessing Enspryng vs PBO in total of 258 adults with active, mod. to sev.…

ByRidhi RastogiJune 30, 2026

Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Nurix Therapeutics Enrolled First Patient in P-III (DAYBreak CLL-306) Trial of Bexobrutideg in R/R CLL/SLL

Top 20 R&D Spending Biopharma Companies of 2026

Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

Top 20 Immunology Companies of 2026

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

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