Roche’ Elecsys pTau217 Test Receives the European CE Mark Approval to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: Roche has received CE Mark for Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology CE Mark was backed by retrospective real-world studies in early-stage Alzheimer’s pts, incl. Subjective Cognitive Decline, Mild Cognitive Impairment, & Mild Dementia, where individuals experience memory changes but…

ByRidhi RastogiMay 12, 2026

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BMS Partners with Hengrui Pharma in a Potential ~$15.2B Deal to Advance 13 Early-Stage Programs Across Oncology, Hematology, and Immunology

Shots: BMS has partnered with Hengrui to advance 13 early-stage programs, incl. 4 Hengrui onco/hemo assets, 4 BMS immunology assets, and 5 jointly discovered & developed candidates; expected to close in Q3’26 Hengrui will lead early clinical development, while BMS gains ex-China rights to Hengrui-originated assets & Hengrui will secure exclusive Greater China rights to…

ByRidhi RastogiMay 12, 2026

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Partner Therapeutics Reports the US FDA Approval of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Shots: The FDA has approved Partner Therapeutics' Bizengri (zenocutuzumab-zbco) under CNPV, for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion who progressed on or after prior systemic therapy Approval was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive advanced solid tumors, incl. cholangiocarcinoma (n=22, where 19 were…

ByRidhi RastogiMay 11, 2026

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PulseSight Therapeutics Reports P-I (PST-611-CT1) Trial Data on PST-611 in Dry AMD/Geographic Atrophy

Shots: PulseSight has presented the P-I (PST-611-CT1) trial data assessing two dose levels (low and high) of PST-611 in two successive dose groups involving 6 pts with late-stage dry AMD/Geographic Atrophy, with a 16wk. follow-up, at ARVO 2026 Trial met its 1 & 2EPs, showing favorable safety & tolerability, along with stable BCVA, no SAEs/SUSARs…

ByRidhi RastogiMay 11, 2026

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argenx Reports the US FDA Approval of Vyvgart and Vyvgart Hytrulo for Generalized Myasthenia Gravis

Shots: The US FDA has approved the label expansion of argenx's Vyvgart (efgartigimod alfa-fcab) & Vyvgart Hytrulo (efgartigimod alfa & hyaluronidase-qvfc) for the treatment of adult pts with gMG, expanding its use in all serotypes of gMG Approval was based on the P-III (ADAPT SERON) study assessing efgartigimod vs PBO in gMG pts (n=119) who…

ByRidhi RastogiMay 11, 2026

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Henlius Receives US FDA IND Clearance for HLX05-N (Biosimilar, Erbitux)

Shots: The US FDA has granted IND clearance to HLX05-N, a biosimilar version of Erbitux (cetuximab) for the treatment of metastatic colorectal cancer (mCRC) HLX05-N is developed by Henlius in accordance with biosimilar guidelines in China, the EU, & the US, and showed high similarity to reference cetuximab in analytical & non-clinical comparative studies Cetuximab…

ByRidhi RastogiMay 11, 2026

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GSK Collaborates with Sino Biopharmaceutical to Accelerate Bepirovirsen at Launch

Shots: GSK has entered an exclusive strategic collaboration with Sino Biopharmaceutical, via its subsidiary CTTQ, to support the launch & commercialization of bepirovirsen (under NMPA’s priority review) in mainland China CTTQ will manage importation, distribution, hospital access, and promotional & non-promotional activities in China under a 5.5yr. supply deal with GSK On the other hand,…

ByRidhi RastogiMay 11, 2026

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BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Shots: FDA has approved BMS' Sotyktu (6mg, PO, QD) ± methotrexate for adults with active PsA who have had an inadequate response or were intolerant to a prior disease-modifying antirheumatic (DMARD) therapy Approval was based on P-III trials, incl. POETYK PsA-1, involving 670 bDMARD-naïve pts, and POETYK PsA-2, involving 624 pts who were bDMARD-naïve &…

ByRidhi RastogiMay 11, 2026

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The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors

Shots: The US FDA has granted IND clearance to initiate the P-I trial assessing the safety, tolerability, PK, & anti-tumor activity of Harbour Biomed's HBM7004 in advanced solid tumors Preclinical studies showed that HBM7004 induced B7H4-dependent intratumoral T-cell activation, strong anti-tumor activity, in vivo stability, & reduced systemic toxicity, while combination with a B7H4x4-1BB BsAb…

ByRidhi RastogiMay 8, 2026

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GSK Partners with Halozyme to Develop SC Formulation of Multiple Oncology Drugs

Shots: GSK has entered into a global collaboration & license agreement with Halozyme to develop & commercialize SC formulation of multiple oncology targets, incl. ADCs, as well as an option for additional future drug targets As per the deal, GSK will license Enhanze drug delivery tech from Halozyme in exchange of upfront payment, as well…

ByRidhi RastogiMay 8, 2026

Ridhi Rastogi

Roche’ Elecsys pTau217 Test Receives the European CE Mark Approval to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

BMS Partners with Hengrui Pharma in a Potential ~$15.2B Deal to Advance 13 Early-Stage Programs Across Oncology, Hematology, and Immunology

Partner Therapeutics Reports the US FDA Approval of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

PulseSight Therapeutics Reports P-I (PST-611-CT1) Trial Data on PST-611 in Dry AMD/Geographic Atrophy

argenx Reports the US FDA Approval of Vyvgart and Vyvgart Hytrulo for Generalized Myasthenia Gravis

Henlius Receives US FDA IND Clearance for HLX05-N (Biosimilar, Erbitux)

GSK Collaborates with Sino Biopharmaceutical to Accelerate Bepirovirsen at Launch

BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors

GSK Partners with Halozyme to Develop SC Formulation of Multiple Oncology Drugs

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