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New Mexico Physician Guilty Plea on Misbranded Drugs

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Deming, NM oncologist Mohamed Basel Aswad enters a guilty plea on charges he caused the unlawful introduction of misbranded drugs ...

FDA OKs Ranbaxy Generic Antara

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FDA approves Ranbaxy Laboratories fenofibrate capsules USP, 43 mg and 130 mg, a generic of Lupins Antara for treating high cholest...

Pediatric Subcommittee to Discuss 3 Cancer Therapies

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 12/11 to discuss pediatric development plans for three pro...

Support Voiced for Duchenne Muscular Dystrophy Guidance

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Comments offer suggestions to strengthen a proposed FDA draft guidance on drug development to treat Duchenne muscular dystrophy.

FDA Grants Orphan Drug to Merrimack for Pancreatic Cancer Drug

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FDA grants orphan drug designation to Merrimack Pharmaceuticalss for its drug candidate MM-141 for treating pancreatic cancer.

Comments Sought on Clinical Trial Regs

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Federal Register Notice: FDA seeks comments on clinical investigation regulations for the safety and effectiveness of unapproved d...

Bio-Rad Labs Pays $14 Mil. Over Illegal Sales to Russia

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Bio-Rad Laboratories agrees to pay a $14.35 million penalty to resolve allegations that it violated the Foreign Corrupt Practices ...

FDA Guidance on Generic Concerta Bioequivalence

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FDA posts a draft guidance on Bioequivalence Recommendations for Concerta (methylphenidate hydrochloride) extended-release tablets...

Novo Nordisk Reports Positive Weight Loss Data with Liraglutide

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Novo Nordisk announces new data from its Phase 3a SCALE obesity and pre-diabetes trial that showed 92% of participants lost weight...

FDA to Appeal Neurontin Generics Orphan Exclusivity Order by Court

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FDA notifies the DC federal district court that it will appeal a 9/5 court order granting Depomeds motion for summary judgment com...