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…
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…
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…
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…
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…
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…
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.…
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…
Shots:
J&J has entered into a definitive agreement to acquire Firefly Bio, incl. its Firelink degrader antibody conjugate (DAC) platform, expanding its oncology pipeline
As per the deal, J&J will acquire Firefly Bio for $1B in cash, with closing expected later this year
The Firelink DAC platform is a targeted protein degradation tech that selectively…
Shots:
Incyte has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, to expand its hematology portfolio into bleeding disorders
As per the deal, Incyte will acquire Vega for $1.25B upfront, with ~$750M in additional payments upon achievement of sales milestones
Acquisition will expand Incyte’s hematology portfolio with…

