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Alnylam Discontinues Revusiran Over Mortality Concerns

[ Price : $8.95]

Alnylam Pharmaceuticals decides to discontinue developing revusiran, an investigational RNA interference therapeutic being develop...

Trice Medical Mi-eye 2 Cleared for Joint Imaging

[ Price : $8.95]

FDA clears a Trice Medical 510(k) for mi-eye 2, a disposable needle with an integrated camera that enables physicians to use advan...

FDA Clears Xenocors Disposable Laparoscope

[ Price : $8.95]

FDA clears a Xenocor 510(k) for the Xenoscope, a single-use disposable laparoscope that will be offered in a sterile condition.

Animal Rights Group Wins Appeal in FDA Case

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The 9th Circuit Court of Appeals orders to trial an Animal Legal Defense Fund suit against FDA over the agencys refusal to provide...

FDA Approves Orexo Zubsolv New Dosage

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FDA approves an Orexo U.S. supplemental NDA for Zubsolv (buprenorphine/naloxone sublingual tablet) 0.7mg/0.18mg for treating patie...

Panel Split on Minimum Dose for New Naloxone Products

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FDAs Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee votes narrow...

New CDER Medical Policy Director Named

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CDER announces the appointment of Jacqueline Corrigan-Curay as director of its Office of Medical Policy.

FDA Clears Viveve System for Vaginal Laxity

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FDA clears a Viveve Medical 510(k) for the Viveve System for use in general surgical procedures for electrocoagulation and hemosta...

Guidance on Developing Drugs for Head Lice

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Federal Register Notice: FDA releases a guidance on Head Lice Infestation: Developing Drugs for Topical Treatment.

Guidance on Tropical Disease Priority Review Vouchers

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Federal Register Notice: FDA announces the availability of a guidance on Tropical Disease Priority Review Vouchers that outlines t...