Biotech Business - April 15, 2025
EU approves Leqembi for treatment of early Alzheimer’s disease
The European Commission has granted BioArctic’s partner Eisai’s application for Marketing Authorization of Leqembi (lecanemab) in the European Union (EU).
Agreement - April 14, 2025
OncoZenge in agreement for BupiZenge in the GCC Region
OncoZenge and Avernus Pharma General Trading, a pharma marketing company from the UAE, have signed an exclusive agreement to license BupiZenge for commercialization and distribution in the Gulf Cooperation Council (GCC) region.
New Market - February 10, 2025
Boule Diagnostics enters distribution agreement
Boule Diagnostics has entered into an exclusive distribution agreement with VitalScientific for the US market.
MedTech Business - February 3, 2025
Suturion receives FDA clearance
The US Food and Drug Administration (FDA) has granted clearance for the surgical device SutureTOOL.
Biotech Business - January 27, 2025
Oncopeptides’ Pepaxti formally approved for full reimbursement in Italy
The positive reimbursement decision for Pepaxti (melflufen) has been published in the Italian Official Journal.
New Market - January 20, 2025
AstraZeneca’s Datroway approved in the US
First approval in the US for AstraZeneca and Daiichi Sankyo’s Datroway based on TROPION-Breast01 results showing 37% reduction in the risk of disease progression or death vs. chemotherapy.
