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The FDA's draft guidance illustrates how a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket...
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Guidance on how to licence electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Pharmaceutical manufacturers have been submitting applications electronically to FDA for years. So the agency’s announcement that it intends to switch its cur
German NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO. Pivotal 6-month data readout for vamorolone in Duchenne muscular dystrophy (DMD) expected in the second quarter of 2021 Organization streamlined with a focus on cost savings and progressing vamorolone Preliminary unaudited result for 2020: net sales CHF 15.0 million; net loss CHF 71.2 million; cash on hand as of December 31, 2020, CHF 12.4 million Upsized financing from fund managed by Highbridge Capital Management, LLC (an existing investor in the Co...