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Regulatory Review Period for Technegas

[ Price : $8.95]

Federal Register notice: FDA determines the regulatory review period for Cyclomedica Australias Technegas (technetium Tc 99m-label...

Regulatory Review Period for Ztalmy

[ Price : $8.95]

Federal Register notice: FDA determines the regulatory review period for Marinus Pharmaceuticals Ztalmy (ganaxolone), indicated fo...

OPDP Hits AbbVie Over Serena Williams DTC Ad

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CDERs Office of Prescription Drug Promotion cites AbbVie in a just-released untitled letter over its television direct-to-consumer...

3 FDA Innovative Manufacturing Action Steps

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FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.

FDA Warns 2 Chinese Labs About Data Concerns

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FDA says it sent Warning Letters to two Chinese nonclinical labs airing concerns about data integrity.

Lawsuit Against FDA Dismissed on Ripeness Grounds

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The Washington, DC District Court dismisses a Vanda Pharmaceuticals lawsuit against FDA that challenged the agencys bioequivalence...

Ocaliva Confirmatory Trial Fails: FDA

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FDA asks members of its Gastrointestinal Drugs Advisory Committee whether they believe that the benefits of using Intercepts Ocali...

GSK Nixes Herpes Simplex Virus Vaccine

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GSK decides to not advance the development of an investigational herpes simplex virus vaccine candidate based on data from a recen...

Hinge Health Wireless Pain Device Cleared

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FDA clears a Hinge Health 510(k) for its Enso 3, a wireless device for reducing musculoskeletal pain.

Syndax Leukemia Review Extended by FDA

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FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...