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Human Drugs

OAC Survey Calls for FDA Action on Obesity Drug Testing, Labeling

An Obesity Action Coalition survey finds that people want FDA and drug companies to change the way that obesity drugs are tested and labeled.

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Human Drugs

FDA Approves Caplyta for Major Depressive Disorder

FDA approves an expanded use for Johnson & Johnsons Caplyta (lumateperone) as an adjunctive therapy with oral antidepressants in adults with major dep...

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Human Drugs

Stop Desiccated Thyroid Enforcement: Congressman

Rep. Abe Hamadeh calls on FDA to suspend any enforcement actions against desiccated thyroid medications due to the possibility that they stemmed from ...

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FDA General

Makary Reassures Stakeholders that FDA Remains Robust

Addressing a Milken Institute annual summit, FDA commissioner Marty Makary reassures stakeholders that despite recent departures among its senior rank...

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Human Drugs

Centessa Promising Data for Sleep Disorder Drug

Centessa Pharmaceuticals reports encouraging clinical data for its oral OX2R agonist ORX750 in patients with narcolepsy Types 1 and 2 and idiopathic h...

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Human Drugs

Liebel-Flarsheim CGMP Violations Cited

FDA warns Liebel-Flarsheim in Raleigh, NC, about CGMP violations in its production of finished drugs.

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Human Drugs

Alembic Pharmaceuticals FDA-483 Out

FDA releases the form FDA-483 with four observations from an inspection at the Alembic Pharmaceuticals active pharmaceutical ingredient manufacturing ...

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HR Complaints Filed Against Prasad: Report

A STAT report highlighted in Medpage says CBER employees are concerned about the environment established by their new director, Vinay Prasad.

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Human Drugs

FDA Rejects Biohavens Troriluzole Application

FDA issues Biohaven a complete response letter, rejecting the companys NDA for Vyglxia (troriluzole) as a treatment for spinocerebellar ataxia.

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Human Drugs

FDA Warns Apotex Canadian Manufacturing Site

FDA issues a Warning Letter to Apotex, citing significant GMP violations at the companys Richmond Hill, Ontario, facility, including failures in steri...