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FDA Releases 15 Million Doses of Janssen Vaccine

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FDA authorizes another vaccine drug substance batch (15 million doses) that was manufactured at troubled Emergent BioSolutions Bal...

FDA Grievously and Horribly Broken: Professor

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University of California San Francisco associate professor of medicine Vinay Prasad says recent FDA actions demonstrate how broken...

Safety Alert on Fumes from Hand Sanitizers

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FDA issues a drug safety alert on alcohol-based hand sanitizers, warning that vapors may cause symptoms such as headache, nausea, ...

Biogen Scraps Investigational Alzheimers Drug

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Biogen halts development of gosuranemab, an investigational anti-tau antibody that was being evaluated as a potential treatment fo...

NeoMedical Screw System for Late-stage Tumors

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FDA clears a Neo Medical 510(k) for the use of its Pedicle Screw System in late stage tumor indications in combination with Osarti...

Tyvaso DPI Pulmonary Hypertension NDA Accepted

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FDA accepts for priority review a United Therapeutics NDA for Tyvaso DPI (inhaled treprostinil) for treating pulmonary arterial hy...

Notice Correction on ANDA Approval Withdrawal

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Federal Register notice: FDA corrects a 5/12 notice about the withdrawal of approval of 12 ANDAs from multiple applicants.

FDA Extends Review Date for Ascendis Lonapegsomatropin

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FDA extends the PDUFA action date for Ascendis lonapegsomatropin to 9/25.

5 More Charged in Drug Diversion Scheme

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The Justice Department says a Florida grand jury indicted five more individuals in a massive drug diversion scheme.

Web Site Selling Illegal New Drugs, FDA Says

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FDA warns the Web site at www.pharmacygeoff.md that it is selling misbranded unapproved new drugs in the U.S.