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This development follows the clearance for an investigational new drug (IND) application by the FDA for the asset last month. The fast track status is expected to expedite

A decision on the approval under the Prescription Drug User Fee Act (PDUFA) is anticipated on 25 January 2025. LEQEMBI is intended to treat AD patients having mild

The investment is managed by the funds of Permira and is expected to close by the fourth quarter of 2024, subject to necessary approvals and conditions. The companies

Currently, AGMB-447 is being assessed in an ongoing Phase I clinical trial as a potential treatment for IPF. The single-centre, integrated trial aims to evaluate the safety, tolerability,

Fast Track process of the FDA is intended to accelerate the development and review of drugs that address serious conditions and fill unmet medical needs. Lunresertib along with

The Department of Health (DoH) Abu Dhabi in the UAE has entered into a memorandum of understanding (MoU) with Pfizer Gulf to bolster research in areas including sickle

TLX250-CDx (Zircaix) is the company’s investigational radiodiagnostic PET agent for the renal masses characterisation as ccRCC or non-ccRCC in a non-invasive manner. Initiated in December 2023, the rolling

The company also launched AutoIND, an AI-powered platform designed to optimise the drafting, reviewing, and submitting of regulatory documents in drug development. AutoIND is the first product on

Octopus Ventures and Redalpine co-led the investment round with contributions from Wilbe Capital, BlueYard Capital, Acequia Capital, Amino Collective, and Hawktail. This funding is set to accelerate the