OR WAIT null SECS
March 08, 2019
Orion Corporation and Bayer have announced the submission of a marketing authorization application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.
OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).
FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.
March 07, 2019
Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.
March 02, 2019
The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
March 01, 2019
Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.
February 25, 2019
A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.
February 21, 2019
As part of its support for novel nicotine replacement therapies, the agency published guidance on the development of these products.
February 20, 2019
The agency clarified the process for development programs for regenerative medicine therapies.