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© 2023 MJH Life Sciences and BioPharm International. All rights reserved.
© 2023 MJH Life Sciences™ and BioPharm International. All rights reserved.
January 23, 2023
In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.
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
The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.
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 company was awarded the Terra Carta Seal in recognition of its commitment to creating a sustainable future.
January 10, 2023
Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.