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Tag Archives: FDA

PharmAthene gets FDA nod on SparVax (access required)

PharmAthene Inc., of Annapolis, a biodefense company developing medical countermeasures against biological and chemical threats, announced that the U.S. Food and Drug Administration has lifted a nearly-10-month hold placed on a proposed Phase II study of SparVax, allowing a clinical trial of the next-generation anthrax vaccine to proceed.

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Maryland to share in Indian drug maker’s settlement (access required)

Maryland will receive $849,259 under a multistate False Claims Act settlement the federal government reached with an India-based generic drug maker in U.S. District Court in Baltimore, the state Office of the Attorney General said Monday.

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FDA OKs Neuralstem’s ALS clinical trial (access required)

Neuralstem Inc., of Rockville, a biotherapeutic company developing products to treat central nervous system disorders with patented stem cell technology, said it received approval from the Food and Drug Administration to begin a Phase II trial using spinal cord-derived human neural stem cells to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

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FDA OKs first-of-a-kind diabetes drug from J&J

WASHINGTON — The Food and Drug Administration says it has approved a first-of-a-kind diabetes drug from Johnson & Johnson that uses a new method to lower blood sugar. The agency cleared J&J’s Invokana tablets for adults with Type 2 diabetes, ...

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