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Sarepta halts Elevidys shipments following FDA pressure
Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.
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Roche halts Elevidys distribution in some countries, following Sarepta's lead in US
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
Makary ally named to key FDA drug post
Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty ...
FDA names former pharmaceutical company executive to oversee US drug program
FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...
FDA reaches out to more than 5k eateries over food safety in a year, but hygiene remains a concern
Pune: A string of recent food safety violations at popular eateries in the city has turned the spotlight onto lax sanitation ...
SPRITAM® (levetiracetam) Tablets for Oral Suspension Approved by FDA for Nasogastric and Gastrostomy Tube Administration
Aprecia, the global leader in 3DP (three-dimensional print) technology for commercial-scale pharmaceutical manufacturing, today announced that the U.S. Food and Drug Administration (FDA) has approved ...