NMPA Accepts IND Application for Harbour BioMed’s HBM7004 to Treat Advanced Solid Tumors

Shots: The NMPA has accepted IND application for HBM7004 for the treatment of advanced solid tumors HBM7004, developed using Harbour’s HBICE platform, is a novel B7H4×CD3 bispecific antibody that is designed to enhance cancer immunotherapy, aiming to improve both efficacy & safety through targeted immune activation In preclinical studies, HBM7004 induced B7H4-dependent T-cell activation within…

ByRidhi RastogiJune 10, 2026

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Oncolys BioPharma Reports MHLW Approval of Telomelysin for Esophageal Cancer

Shots: The Japanese MHLW has granted full marketing approval to Telomelysin Injection (suratadenoturev/OBP-301) for the treatment of esophageal cancer pts ineligible for curative resection or CT, based on a Japanese pivotal trial conducted at 17 sites Approval triggered a milestone payment to Oncolys under its deal with FUJIFILM Toyama Chemical, which granted FUJIFILM commercialization rights…

ByRidhi RastogiJune 10, 2026

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Vara Secures CE Mark for AI-Powered Tomosynthesis Solution

Shots: Vara has received CE Class IIb marking under the EU MDR for its tomosynthesis (3D mammography) AI solution, expanding its offerings for breast cancer screening programs across the EU Vara is validated for national-scale breast cancer screening, with its scale demonstrated through PRAIM, a large prospective screening study published in Nature Medicine in 2025, supporting…

ByRidhi RastogiJune 10, 2026

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SpinaFX Receives the US FDA IDE Approval to Initiate Trial for Triojection Therapy

Shots: The US FDA has granted an IDE approval to Triojection therapy to initiate US trial in pts with contained herniated lumbar discs who have not responded to conservative therapy The trial is expected to enroll 300 pts across ~30 specialty spine centers, comparing intradiscal ozone/oxygen injection plus nerve root block against nerve root block…

ByRidhi RastogiJune 10, 2026

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Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis

Shots: The US FDA has approved Ebglyss (lebrikizumab-lbkz; 250mg/2mL, Q8W, SC) maintenance therapy for the treatment of pts (≥12yrs.; ≥40kg) with mod. to sev. atopic dermatitis Approval was supported by longitudinal exposure-response modeling & Q8W dosing data from an extension of the P-III (Adjoin) long-term trial, which assessed Ebglyss maintenance dosing for Q4W or Q8W over…

ByRidhi RastogiJune 10, 2026

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Xenix Medical Reports the US FDA Clearance for Lux Expandable Lumbar Fusion System

Shots: Xenix Medical has received the US FDA 510(k) clearance & initiated the full commercial launch of its Lux Expandable Lumbar Interbody Fusion System Lux features up to 4.5mm of controlled post-implant expansion, enables bone graft delivery through the inserter into a large endplate-to-endplate graft window after expansion, & incorporates NanoACTIV surface tech. to support fusion…

ByRidhi RastogiJune 9, 2026

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Novanta to Acquire Riverpoint Medical in ~$1.45B Deal

Shots: Novanta has entered into a definitive agreement to acquire Riverpoint Medical from Arlington Capital Partners, expanding Novanta’s presence in the minimally invasive surgery market As per the deal, Novanta will acquire Riverpoint for $1.2B upfront, with $250M in milestone payments expected in Q1’27, representing the total deal value of $1.45B; closing is anticipated in…

ByRidhi RastogiJune 9, 2026

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Zai Lab Reports the NMPA Approval of Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Shots: The Chinese NMPA has approved Zai lab's Tivdak for the treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after CT Approval was backed by the global P-III (innovaTV 301) trial evaluating Tivdak vs CT alone, which met its 1EP of improved OS in the IIT population In the…

ByRidhi RastogiJune 9, 2026

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Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

Shots: The US FDA has approved Pfizer's Hympavzi for the treatment of pts (≥12yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B with or without inhibitors Approval of Hympavzi (SC, QW) in pts (≥12yrs.) was supported by the P-III (BASIS) trial, showing improved key bleeding outcomes incl.…

ByRidhi RastogiJune 9, 2026

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GSK to Acquire Nuvalent for ~$10.6B

Shots: GSK has entered an agreement to acquire Nuvalent, accelerating its entry into lung cancer As per the deal, GSK will acquire Nuvalent through a tender offer of $124 per share in cash, valuing the company at ~$10.6B (£8.0B); net of acquired cash, GSK’s total investment is estimated at $9.4B (£7.1B). Closing is expected in…

ByRidhi RastogiJune 9, 2026

Ridhi Rastogi

NMPA Accepts IND Application for Harbour BioMed’s HBM7004 to Treat Advanced Solid Tumors

Oncolys BioPharma Reports MHLW Approval of Telomelysin for Esophageal Cancer

Vara Secures CE Mark for AI-Powered Tomosynthesis Solution

SpinaFX Receives the US FDA IDE Approval to Initiate Trial for Triojection Therapy

Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis

Xenix Medical Reports the US FDA Clearance for Lux Expandable Lumbar Fusion System

Novanta to Acquire Riverpoint Medical in ~$1.45B Deal

Zai Lab Reports the NMPA Approval of Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

GSK to Acquire Nuvalent for ~$10.6B

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