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The regulatory round-up: Eight key FDA decisions

Drug Discovery World

The designation is the first step to gaining a priority review voucher (PRV), which can accelerate market access for therapeutics. The Food and Drug Administration (FDA) in the US has made several key drug decisions over the last few weeks. Here’s a summary. The drug was granted orphan drug designation by the FDA in May 2021.

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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Due to the high costs associated with new drug development, pharmaceutical companies are under pressure to get effective drugs to market as fast as possible while ensuring they are safe for the intended patient population and dosing timeline, which can be lifelong for some drugs. billion and take over 10 years.

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BioSpace Global Roundup, Oct. 15

The Pharma Data

VBL has recently demonstrated ex-vivo activity of anti-MOSPD2 antibodies in patients with relapsing-remitting and progressive multiple sclerosis (MS), as well as in animal models of rheumatoid arthritis (RA), nonalcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD). 1. -- -->. -- [if lte IE 8]--> .