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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Lupin Ltd., ProSun International and RTI Surgical.

Expanded Use for Vraylar in Schizophrenia Approved

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FDA approves an Allergan supplemental NDA for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia.

Trump Nominates Alex Azar as Next HHS Secretary

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President Donald Trump nominates former Eli Lilly executive Alex Azar as the next HHS secretary, replacing former Rep. Tom Price, ...

Pharmacy Owner Pleads Guilty in $100 Million Compounding Fraud

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The president and owner of a Florida pharmacy pleads guilty for his role in a $100 million compounding pharmacy fraud scheme, whic...

Theravance/Mylan NDA for COPD Drug

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Theravance Biopharma and Mylan NV file an NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist as a...

Hospital Group Urges FDA to Help More with Product Shortages

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The American Hospital Association urges FDA to intervene and expedite the resolution of the worsening shortages of small-volume pa...

Test for Detecting Blood in Stool Cleared

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FDA clears a Clinical Genomics and Quest Diagnostics 510(k) for its InSure One, an at-home collection, fecal immunochemical test i...

FDA Approves Redesigned Gonal-f Redi-ject Pen

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FDA approves an EMD Serono supplemental NDA for a redesigned version of Gonal-f RFF Redi-ject (follitropin alfa injection) pen inj...

NDA Accepted for Sunovian ADHD Drug

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FDA accepts for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake in...

FDA Approves Dynavax BLA for Hepatitis B Vaccine

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FDA approves a Dynavax Technologies BLA for Heplisav-B [hepatitis b vaccine, recombinant (adjuvanted)] for immunization against he...