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Before the end of the year, the FDA will begin requiring that study data for NDA, BLA, and ANDA submissions be submitted to the agency in a standardized electronic data format. Read More
The Office of Generic Drugs topped last year’s approval and rejection rates, issuing 835 tentative or full approvals and 1,725 complete response letters in fiscal 2016. Read More
The EMA Management Board has advanced the development of a web portal that will provide free information on European medicines across the products’ lifecycle. Read More
The UK’s price watchdog is backing Celgene’s Otezla as a standalone or combined treatment for active psoriatic arthritis when other options are ineffective or not tolerated, provided the company discounts its price. Read More
Bristol-Myers Squibb presented results from several clinical trials of its PD-L1 immunotherapy, Opdivo, including more detailed data from a Phase III trial that failed to show benefits as a first-line monotherapy in advanced non-small cell lung cancer. Read More
The pharmaceutical industry is generally satisfied with the EMA’s redesigned post-approval procedures, but would like some clarity on how to tackle more complex filings, according to an EMA survey. Read More