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FDA Supports WHO Drug Dictionary

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Federal Register notice: FDA announces support for the most current B3-format annual version of the World Health Organization Drug...

FDA Debars Nguyen over Misdemeanor Conviction

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Federal Register notice: FDA denies a request for a hearing and issues an order debarring Trang Doan Nguyen for five years from pr...

FDA Approves AstraZeneca NDA for Bydureon BCise

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FDA approves an AstraZeneca NDA for Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation designed ...

AstraZenecas Elavil Not Withdrawn Due to Safety/Effectiveness

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Federal Register notice: FDA determines that AstraZenecas Elavil (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, ...

Biosimilar Savings Projected at $54 billion Over Next Decade

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A new analysis from the RAND Corporation says biosimilar approvals should help cut healthcare spending by $54 billion over the nex...

FDA Determines Regulatory Review Period for Baxters Obizur

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Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Baxters Obizur is 4,21...

Draft Guide for Methylphenidate Hydrochloride ANDAs

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Federal Register notice: FDA makes available a new draft guidance for industry on generic methylphenidate hydrochloride oral exten...

Regulatory Review Period for Inspire Sleep Apnea Device

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FDA determines for patent extension purposes that the regulatory review period for Baxters Obizur is 4,216 days.

FDA Approves Janssens Simponi Aria for 2 New Indications

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FDA approves Janssen Biotechs Simponi Aria (golimumab) for treating adults with active psoriatic arthritis and active ankylosing s...

FDA Approves Glaxos Shingrix Shingles Vaccine

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FDA approves a GlaxoSmithKline BLA for its Shingrix (zoster vaccine recombinant, adjuvanted) for preventing shingles (herpes zoste...