NEWS

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…

May 11, 2026

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…

May 11, 2026

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…

May 11, 2026

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…

May 11, 2026

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,…

May 11, 2026

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 &…

May 11, 2026

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…

May 8, 2026

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…

May 8, 2026

Bausch + Lomb Launches Bi-Blade+ Vitrectomy Cutter in the EU on Stellaris Elite Platform

Shots: Bausch + Lomb has launched Bi-Blade+ advanced dual-port vitrectomy cutter on the Stellaris Elite Vision Enhancement System in the EU for anterior & posterior segment procedures requiring vitreous removal Bi-Blade+ delivers a 25% higher flow rate for more efficient vitreous removal compared to Bi-Blade & demonstrated a 62% reduction in cutter vibration, aimed at…

May 8, 2026

ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26

Shots: ALX Oncology presented data from exploratory analyses of P-Ib/II trial assessing evorpacept + Ziihera in pts with heavily pre-treated HER2+ mBC, all of whom had received prior Enhertu therapy, at ESMO Breast Cancer 2026 Exploratory analyses in 24 pts treated with evorpacept + Ziihera at dosages of 20mg/kg (n=3) or 30mg/kg (n=21), showed a…

May 8, 2026

NEWS

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

Bausch + Lomb Launches Bi-Blade+ Vitrectomy Cutter in the EU on Stellaris Elite Platform

ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26

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