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NEWS

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…
June 10, 2026
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…
June 10, 2026
Organon Receives the US FDA Approval for the sBLA for Tofidence (Biosimilar, Actemra) 
Shots:  The US FDA has approved sBLA for Tofidence, a biosimilar version of Actemra (tocilizumab)  Tofidence is an IL-6 receptor antagonist available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL single-dose vials for IV. The expanded approval adds indications for CAR T cell-induced severe or life-threatening cytokine release syndrome (CRS) and hospitalized adults and children (≥2 years) with COVID-19 requiring…
June 10, 2026
Eli lilly
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…
June 10, 2026
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…
June 9, 2026
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…
June 9, 2026
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…
June 9, 2026
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