Daiichi Sankyo Initiates P-III (TROPIONLung17) Trial of Datroway in Nonsquamous NSCLC

Shots: Daiichi Sankyo has dosed the first patient in the P-III (TROPIONLung17) trial of Datroway for TROP2-NMR–positive LA/M nonsq. NSCLC without actionable genomic alterations previously treated with immunotherapy (IT) & Pt-based CT Trial will evaluate Datroway (6mg/kg) vs docetaxel in above-mentioned pts (n=~400) across Asia, EU & North America, assessing PFS & OS as dual…

ByRidhi RastogiJanuary 14, 2026

NEWS

Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

Shots: The US FDA has approved Zycubo (copper histidinate) for the treatment of pediatric patients with Menkes disease Approval was supported by clinical data showing improved OS with early Zycubo treatment vs an untreated external control, reflecting ~80% reduction in the risk of death & a mOS of 177.1 vs 17.6mos. Zycubo is a bioavailable…

ByRidhi RastogiJanuary 14, 2026

NEWS

PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia

Shots: The US FDA has accepted sBLA of ropeginterferon alfa-2b-njft for the treatment of adults with essential thrombocythemia, with a PDUFA target action date of Aug 30, 2026 sBLA is supported by the statistically significant and clinically meaningful data from the P-III (SURPASS-ET) trial as well as North American P-IIb (EXCEED-ET) trial Ropeginterferon alfa-2b-njft received…

ByRidhi RastogiJanuary 14, 2026

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Zonsen PepLib Biotech Grants Novartis Global License for Radioligand Therapy Asset with $50M Upfront

Shots: Zonsen PepLib Biotech has entered into a worldwide license agreement with Novartis for an undisclosed peptide-based radioligand therapy asset As per the deal, Novartis will obtain exclusive worldwide rights & lead the development & commercialization activities for the undisclosed asset In return, PepLib will receive $50M upfront, with additional development, regulatory, & sales milestone payments,…

ByRidhi RastogiJanuary 14, 2026

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Summit Therapeutics Reports the US FDA’s BLA Submission for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has received BLA of ivonescimab + CT for ≥2L treatment of pts with EGFR-mutated locally advanced or metastatic non-squamous NSCLC; decision is expected by Q4’26 BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC…

ByRidhi RastogiJanuary 13, 2026

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Medtronic Reports 510(k) Clearance of MiniMed Go System for Diabetes Management

Shots: FDA has granted 510(k) clearance to MiniMed Go app, powering the MiniMed Go Smart MDI system that integrates the InPen smart insulin pen with Abbott’s Instinct glucose sensor for diabetes management; commercial launch expected in spring of 2026 The MiniMed Go system is cleared for people with insulin-requiring type 1 & type 2 diabetes…

ByRidhi RastogiJanuary 13, 2026

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BMS Reports P-III (SCOUT-HCM) Trial Findings on Camzyos for Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: BMS reported topline P-III (SCOUT-HCM) trial data evaluating Camzyos (mavacamten) in 44 adolescents (12 to <18yrs.) with symptomatic oHCM, comprising a 28wk. PBO-controlled phase, an ongoing 28wk. active-treatment phase, & a 144wk. open-label LTE Trial met its 1EP, showing reduced Valsalva LVOT gradient at Wk. 28, & achieved statistical significance across multiple 2EPs, incl.…

ByRidhi RastogiJanuary 13, 2026

NEWS

SciNeuro Forges ~$1.7B Deal with Novartis to Advance Therapeutics for Alzheimer’s Disease

Shots: SciNeuro has entered into a global licensing & collaboration deal with Novartis to advance its amyloid beta-targeted antibody program for Alzheimer’s disease The program has identified de novo antibody candidates using SciNeuro’s blood–brain barrier shuttle tech, with Novartis leading global development & commercialization after collaboration on early development As per the deal, SciNeuro will…

ByRidhi RastogiJanuary 13, 2026

NEWS

Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: The US FDA has accepted the NDA of Merck KGaA's Pimicotinib (PO) for the systemic treatment of adults with TGCT following NMPA approval NDA was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which Part 1 randomized 94 pts…

ByRidhi RastogiJanuary 13, 2026

NEWS

AbbVie Enters PD-1×VEGF Bispecific Race with ~$5.6B Deal for Remegen’s RC148

Shots: RemeGen has granted AbbVie exclusive rights to develop, manufacture, & commercialize RC148 outside of the Greater China In return, RemeGen will receive $650M upfront, ~$4.95B in development, regulatory, & commercial milestones, with tiered, double-digit royalties on sales in AbbVie’s licensed areas RC148 is a PD-1/VEGF-targeted bispecific antibody that is being developed as a monotx.…

ByRidhi RastogiJanuary 13, 2026

Ridhi Rastogi

Daiichi Sankyo Initiates P-III (TROPIONLung17) Trial of Datroway in Nonsquamous NSCLC

Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

PharmaEssentia Reports the US FDA’s sBLA Acceptance of Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia

Zonsen PepLib Biotech Grants Novartis Global License for Radioligand Therapy Asset with $50M Upfront

Summit Therapeutics Reports the US FDA’s BLA Submission for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Medtronic Reports 510(k) Clearance of MiniMed Go System for Diabetes Management

BMS Reports P-III (SCOUT-HCM) Trial Findings on Camzyos for Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

SciNeuro Forges ~$1.7B Deal with Novartis to Advance Therapeutics for Alzheimer’s Disease

Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

AbbVie Enters PD-1×VEGF Bispecific Race with ~$5.6B Deal for Remegen’s RC148

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