The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer

Shots: The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or…

ByDipanshu DixitFebruary 20, 2026

NEWS

STADA & Bio-Thera Receive the EC approval for Gotenfia (Biosimilar, Simponi)

Shots: The EC has approved STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), in all 30 EEA states, with launch preparations ongoing Approval was based on extensive analytical, non-clinical & clinical data demonstrating biosimilarity of BAT2506 to Simponi In May 2024 deal, STADA obtained exclusive commercial rights to Gotenfia…

ByRidhi RastogiFebruary 16, 2026

NEWS

Labcorp Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

Shots: Labcorp has launched the Elecsys pTau-181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.) The test delivers a 97.9% negative predictive value to help rule out Alzheimer’s pathology in symptomatic pts & offers a less invasive, more accessible alternative to brain scans or lumbar punctures…

ByRidhi RastogiFebruary 12, 2026

TOP 20

Top 20 M&A of 2025 by Total Deal Value

Shots: 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…

ByPrince GiriJanuary 30, 2026

NEWS

Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Shots: Roche reported positive topline results from the P-II (CT388-103) study evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist, for the treatment of obesity Once-weekly CT-388 (SC) achieved a statistically significant PBO-adjusted weight loss of 22.5% (p<0.001; efficacy estimand) at 48 wks. at the highest dose (24 mg), with no weight-loss plateau observed; 54% of…

ByPrince GiriJanuary 28, 2026

NEWS

Roche Signs an Exclusive Licensing Deal with MediLink Therapeutics for YL201

Shots: MediLink has entered into an additional collaboration & exclusive licensing agreement with Roche for the development & commercialization of YL201 (B7H3 ADC) across numerous solid tumor types Under the deal, Roche will obtain an exclusive license to develop, manufacture, & commercialize YL201 worldwide, excl. Mainland China, Hong Kong SAR, & Macau SAR In return,…

ByRidhi RastogiJanuary 9, 2026

NEWS

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

Shots: The US FDA has approved Roche’s Lunsumio VELO (mosunetuzumab) as an SC formulation for the treatment of adults with r/r follicular lymphoma (FL) after ≥2L of systemic therapy, under accelerated approval Approval was based on the P-I/II (GO29781) study in third-line or later FL pts, where Lunsumio VELO demonstrated an ORR of 75% and…

ByPrince GiriDecember 23, 2025

NEWS

STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Shots: The CHMP has recommended STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), for EC approval valid in all 30 EEA states Opinion was based on extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III…

ByRidhi RastogiDecember 12, 2025

NEWS

Roche Reports P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Shots: Roche has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer At the interim analysis, trial met its 1EP of improved invasive disease-free survival (iDFS) by 30%, with 92.4% vs 89.6% pts alive & invasive disease free…

ByRidhi RastogiDecember 11, 2025

NEWS

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Shots: Roche has received 510(k) clearance with CLIA waiver & CE-IVDR certification for its point-of-care test to diagnose whooping cough (pertussis) & other Bordetella infections The PCR test on the cobas liat system delivers results in 15min. in GP clinics & emergency rooms, allowing real-time diagnosis during consultation & supporting immediate antibiotic decisions to help…

ByRidhi RastogiDecember 2, 2025

The US FDA Accepts Roche’s Giredestrant NDA for ESR1-Mutated, ER-Positive Advanced Breast Cancer

STADA & Bio-Thera Receive the EC approval for Gotenfia (Biosimilar, Simponi)

Labcorp Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

Top 20 M&A of 2025 by Total Deal Value

Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Roche Signs an Exclusive Licensing Deal with MediLink Therapeutics for YL201

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Roche Reports P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Contact US

FOLLOW US