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January 16, 2023
The guidance provides examples of required and recommended information in the Dosage and Administration section.
The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.
The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.
January 13, 2023
The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy.
It is intended to identify the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning.
January 11, 2023
This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.
Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.
A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.
The definitive agreement will give AstraZeneca global rights to CinCor’s portfolio of cardiorenal disease treatments.
Chiesi will acquire Amryt Pharma, a commercial-stage biopharmaceutical company, in a deal worth up to $1.47 billion.