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

NEWS

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%) IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…

ByRidhi RastogiJuly 15, 2026

NEWS

Insilico Medicine and Bora Pharmaceuticals Form AI-Driven Alliance with Potential Value Exceeding $2.5B

Shots: Insilico has entered into a multi-target strategic alliance with Bora to combine its Pharma.AI platform with Bora's expertise in drug development, manufacturing, quality, & commercialization Insilico will provide end-to-end AI solutions and R&D strategies to accelerate Bora’s AI- & automation-driven drug discovery & development, with plans to expand AI across development planning, process optimization,…

ByRidhi RastogiJuly 15, 2026

NEWS

The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

Shots: FDA has approved Revtorpyk for HR+, HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer that has progressed after ≥1L of endocrine therapy (ET) in the metastatic setting; launch expected in late Q3’26 Approval was backed by PIK3CA wild-type cohort data from P-III (VIKTORIA-1), where Revtorpyk + fulvestrant + palbociclib improved mPFS (9.3 vs…

ByRidhi RastogiJuly 15, 2026

NEWS

Innovent Biologics Licenses SP001 (IBI355) to Spero Therapeutics in a ~$1.1B Deal

Shots: Innovent will grant Spero Therapeutics exclusive rights to develop, research, manufacture, & commercialize SP001 worldwide, excl. Greater China, where Innovent will retain the rights In return, Innovent will receive an upfront payment & development, regulatory & commercial milestone payments, representing the total deal value of ~$1.1B, plus Innovent will also receive tiered royalties on…

ByRidhi RastogiJuly 14, 2026

NEWS

BioMarin Reports the US FDA’s sNDA Acceptance for Full Approval of Voxzogo in Achondroplasia

Shots: The US FDA has accepted an sNDA for Voxzogo (vosoritide) for full approval in children with achondroplasia (PDUFA: Feb. 28, 2027) The sNDA was supported by long-term safety & efficacy data from the ongoing 111-205, 111-208, & 111-302 studies, demonstrating clinically meaningful improvements in growth & key skeletal measures, incl. body proportionality & arm span…

ByRidhi RastogiJuly 14, 2026

NEWS

HistoSonics Reports CE Mark Approval of Edison System for Unresectable Liver Tumors

Shots: HistoSonics has reported CE Mark approval of its Edison System for the non-invasive mechanical destruction of liver tumors, incl. the partial or complete destruction of unresectable liver tumors using histotripsy Approval was supported by clinical evidence, incl. HOPE4LIVER trial, which demonstrated a 90% local tumor control rate at 12mos. across liver tumor types with…

ByRidhi RastogiJuly 14, 2026

NEWS

Dizal Inks ~$1.5B Global Exclusive License Agreement with AstraZeneca for Zegfrovy

Shots: Dizal has entered into a global exclusive license agreement with AstraZeneca for Zegfrovy (sunvozertinib) for the treatment of pts with lung cancer; closing is expected in H2’26 As per the deal, AstraZeneca will acquire worldwide rights to develop & commercialise Zegfrovy in exchange for $600M upfront, & ~$900M in development, regulatory & sales milestones, with tiered royalties…

ByRidhi RastogiJuly 14, 2026

NEWS

Universal Brain Reports FDA Clearance of UB ERP System for Rapid Brain-Function Measurement

Shots: The US FDA granted 510(k) clearance to the UB ERP System for electroencephalography & event-related potentials-based brain function assessment, with commercial launch expected later this year To support clinical expansion, the company initiated US & Japan studies in depression to evaluate brain function before & after 1L antidepressant treatment, and develop objective brain function…

ByRidhi RastogiJuly 14, 2026

NEWS

Eisai and Biogen Report US FDA Approval of Leqembi Iqlik as an Initiation Dose for Early Alzheimer’s Disease

Shots: The US FDA has approved an sBLA for Leqembi Iqlik (lecanemab‑irmb, SC) as an initiation dose administered as 500mg given QW as two 250mg injections, each delivered in ~15secs for the treatment of early Alzheimer's disease Approval was supported by clinical data across multiple studies, with Clarity AD LTE sub-studies showing QW SC Leqembi…

ByRidhi RastogiJuly 14, 2026

Ridhi Rastogi

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

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Insilico Medicine and Bora Pharmaceuticals Form AI-Driven Alliance with Potential Value Exceeding $2.5B

The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

BioMarin Reports the US FDA’s sNDA Acceptance for Full Approval of Voxzogo in Achondroplasia

HistoSonics Reports CE Mark Approval of Edison System for Unresectable Liver Tumors

Dizal Inks ~$1.5B Global Exclusive License Agreement with AstraZeneca for Zegfrovy

Universal Brain Reports FDA Clearance of UB ERP System for Rapid Brain-Function Measurement

Eisai and Biogen Report US FDA Approval of Leqembi Iqlik as an Initiation Dose for Early Alzheimer’s Disease

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