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January 23, 2023
The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.
January 20, 2023
CRB’s latest industry report includes an expanded audience to include many European countries, which has provided some interesting insights.
January 18, 2023
Vetter significantly increases its sustainability ranking by achieving gold status in EcoVadis ranking.
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 11, 2023
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.