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news.Affinia receives FDA fast track designation for AFTX-201
AFTX-201 is being evaluated as a one-time intravenous gene therapy in adults with genetically confirmed BAG3 DCM. The therapy delivers a fully human, full-length BAG3 transgene using the
AFTX-201 is being evaluated as a one-time intravenous gene therapy in adults with genetically confirmed BAG3 DCM. The therapy delivers a fully human, full-length BAG3 transgene using the
Alprazolam is the active pharmaceutical ingredient (API) in Xanax, a commonly prescribed anti-anxiety medication. Traditional oral alprazolam tablets can require 25 minutes or more to take effect, as
Enbumyst is approved by the US Food and Drug Administration (FDA) for treating oedema linked to congestive heart failure, hepatic, and renal diseases in adults. The agreement will
Following completion, the combined entity will operate as Candid Therapeutics and list on Nasdaq under the “CDRX” ticker symbol. As part of the merger, Candid has secured more
CL-273 is a reversible, investigational, wild-type-sparing pan epidermal growth factor receptor (EGFR) small molecule inhibitor developed using an AI-based drug discovery platform. The asset specifically targets resistant mutations
The recommendation applies to children aged two to 11 years experiencing moderate-to-severe CSU who do not respond adequately to histamine-1 antihistamines and are naïve to anti-immunoglobulin E (IgE) therapy.
This makes Palynziq the only enzyme substitution therapy that received approval to reduce blood phenylalanine (Phe) concentrations in individuals with PKU. The approval follows data from PEGASUS, a
The acquisition will expand the company’s speciality pharmaceutical platform into severe infectious diseases. Completion is expected in the first quarter of fiscal 2026, subject to customary conditions. The
FOP is an ultra-rare condition, impacting fewer than 1,000 people worldwide. The collaboration involves containment, specialised handling, and sustained supply of this highly potent molecule. The agreement includes
The acquisition includes five sites specialising in various in vitro drug discovery services such as New Approach Methodologies (NAMs) and a small molecule AI platform. These assets are