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FDA Approves Caplyta for Major Depressive Disorder

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

Stop Desiccated Thyroid Enforcement: Congressman

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Rep. Abe Hamadeh calls on FDA to suspend any enforcement actions against desiccated thyroid medications due to the possibility tha...

Makary Reassures Stakeholders that FDA Remains Robust

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

Centessa Promising Data for Sleep Disorder Drug

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Centessa Pharmaceuticals reports encouraging clinical data for its oral OX2R agonist ORX750 in patients with narcolepsy Types 1 an...

Liebel-Flarsheim CGMP Violations Cited

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

Alembic Pharmaceuticals FDA-483 Out

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

HR Complaints Filed Against Prasad: Report

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

FDA Rejects Biohavens Troriluzole Application

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

FDA Warns Apotex Canadian Manufacturing Site

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

White House Supporting Makary in Turmoil: Report

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Politico reports that President Trump and HHS are standing by FDA commissioner Marty Makary as the agency weathers the sudden depa...