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August 02, 2019
A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.
Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.
August 01, 2019
A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.
Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.
July 31, 2019
Daiichi Sankyo Europe has revealed the results of a Phase III study assessing the efficacy, safety, and tolerability of bempedoic acid/ezetimibe fixed-dose combination (FDC) tablet.
Orion Corporation announced it has received approval from the US Food and Drug Administration for darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC).
July 17, 2019
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
July 11, 2019
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
July 10, 2019
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.