Invenio Imaging Completes Enrollment in Pivotal ON-SITE Study for NIO Lung Cancer Reveal

Shots: Invenio has completed patient enrollment in the ON-SITE study evaluating NIO Lung Cancer Reveal, an AI-based image analysis module for rapid assessment of bronchoscopic lung biopsy specimens imaged with the NIO Imaging System The study enrolled 1,006 pts, involving >3,250 fresh biopsy specimens across 7 US medical centers, with specimens collected using transbronchial forceps biopsy,…

ByRidhi RastogiAugust 3, 2026

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Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

Shots: The US FDA has approved Garzulys (SC & IV), a biosimilar to NovoLog (insulin aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus Garzulys was developed through a collaboration among Tonghua Dongbao, NKF, Xentria, Meitheal, & Emerge. Tonghua Dongbao developed the drug substance, NKF the drug product, Xentria led clinical…

ByRidhi RastogiAugust 3, 2026

NEWS

Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC

Shots: The NMPA has approved IND application to initiate P-Ib/II trial of opamtistomig (LBL-024) in combination therapy for metastatic colorectal cancer (mCRC) Trial will evaluate the safety & efficacy of opamtistomig combination regimens in pts with mCRC & explore potential predictive biomarkers. Opamtistomig mechanism was already validated across EP-NEC, NSCLC, SCLC, & biliary tract cancer…

ByRidhi RastogiAugust 3, 2026

NEWS

Fresenius Kabi & Dr Reddy’s Laboratories Reports the US FDA Approval of Rituximab (Biosimilar, Rituxan)

Shots: The US FDA has approved Rituximab, a biosimilar version of Rituxan developed by Dr. Reddy's Laboratories, supported by analytical, non-clinical, and clinical data demonstrating high similarity and no clinically meaningful differences from Rituxan, meeting US biosimilar requirements Rituximab is a mAb targeting CD20 on B cells, leading to B-cell depletion through immune-mediated mechanisms. It is approved in the US for…

ByRidhi RastogiAugust 3, 2026

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Ractigen Therapeutics Reports IND Clearance of RAG-1C for Proliferative Vitreoretinopathy

Shots: The US FDA has granted IND clearance for RAG-1C for the prevention & treatment of Proliferative Vitreoretinopathy (PVR) The P-I trial will assess the safety, tolerability, PK, & preliminary efficacy of RAG-1C in patients undergoing surgery for retinal detachment who are at high risk of developing PVR RAG-1C is an intravitreal saRNA therapy using Ractigen’s…

ByRidhi RastogiAugust 3, 2026

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Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review

Shots: The US FDA and EMA have accepted the BLA & MAA, respectively, for PB016, a biosimilar version of Entyvio (vedolizumab) lyophilized vial for IV administration BLA was supported by an extensive development program assessing PB016 vs Entyvio, to evaluate its similarity to the reference product, consistent with regulatory requirements for biosimilar approval PB016 is…

ByRidhi RastogiAugust 3, 2026

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Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Shots: The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with an androgen receptor pathway inhibitor (ARPI) for pts with PSMA+ metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer Approval was based on the P-III (PSMAddition) trial, which showed Pluvicto + ARPI & ADT reduced the risk of progression or death by 28% vs SoC…

ByRidhi RastogiAugust 3, 2026

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Cytokinetics Reports MHRA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The MHRA has approved Cytokinetics’ Myqorzo (aficamten) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM MHRA assessment was based on P-III (SEQUOIA-HCM) trial of Myqorzo (n=282), showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min Additionally, NICE has recommended aficamten for eligible…

ByRidhi RastogiJuly 30, 2026

NEWS

Relation and GSK Partner to Advance Drug Discovery

Shots: Relation has entered a strategic research collaboration with GSK to generate large-scale human cellular perturbation datasets to understand disease biology & discover novel therapeutic targets Relation will generate large-scale perturbation datasets using advanced human cellular disease models & experimental systems to develop, validate, & train foundation models, incl. MORGAN, to investigate disease biology &…

ByRidhi RastogiJuly 30, 2026

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Synlogic and Caldera Report Merger Agreement and Concurrent $278M Private Placement to Advance CLD-423

Shots: Synlogic & Caldera have agreed to merge in an all-stock transaction, forming a new holding company that will operate as Caldera Therapeutics & plans to list on Nasdaq under the ticker “CALD” Upon closing, Synlogic, Caldera, and private placement investors are expected to own ~2.3%, ~62.8%, and ~34.9% of the combined company, respectively, with…

ByRidhi RastogiJuly 30, 2026

Ridhi Rastogi

Invenio Imaging Completes Enrollment in Pivotal ON-SITE Study for NIO Lung Cancer Reveal

Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC

Fresenius Kabi & Dr Reddy’s Laboratories Reports the US FDA Approval of Rituximab (Biosimilar, Rituxan)

Ractigen Therapeutics Reports IND Clearance of RAG-1C for Proliferative Vitreoretinopathy

Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review

Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Cytokinetics Reports MHRA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Relation and GSK Partner to Advance Drug Discovery

Synlogic and Caldera Report Merger Agreement and Concurrent $278M Private Placement to Advance CLD-423

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