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Human Drugs

6 Additional National Priority Vouchers Awarded

FDA announces six additional drugs awarded Commissioners National Priority vouchers.

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Human Drugs

18 Web Sites Warned About Illegal Botox Sales

FDA warns 18 Internet companies that they are illegally selling Botox products.

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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

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...

Human Drugs

2 CGMP Issues in Scientific Protein Inspection

FDA warns Waunakee, WI-based Scientific Protein Laboratories about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

FDA General

White House Supporting Makary in Turmoil: Report

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

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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...