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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

6 Additional National Priority Vouchers Awarded

FDA announces six additional drugs awarded Commissioners National Priority vouchers.

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Human Drugs

White House Inks Deals with Lilly and Novo Nordisk

The Trump Administration announces new agreements with Eli Lilly and Novo Nordisk to lower U.S. prices for several products, including the GLP-1 medic...

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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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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

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

Baxter Oncology FDA-483 Out

FDA releases the form FDA-483 with six observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle, Westfalen, Germany...

Human Drugs

76 New or Revised Product-Specific Guidances Out

FDA publishes 76 new and revised product-specific guidances intended to speed generic drug development and approval.

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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...