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FDA Posts Biohaven Troriluzole Complete Response Letter

[ Price : $8.95]

FDA publicly releases an 11/4 complete response letter issued to Biohaven on its NDA seeking approval for troriluzole to treat spi...

FDA Extends Review of Rhythms Setmelanotide sNDA

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FDA extends by three months its review of Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) and its use in trea...

Baxter Oncology FDA-483 Out

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

76 New or Revised Product-Specific Guidances Out

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

White House Inks Deals with Lilly and Novo Nordisk

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The Trump Administration announces new agreements with Eli Lilly and Novo Nordisk to lower U.S. prices for several products, inclu...

6 Additional National Priority Vouchers Awarded

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FDA announces six additional drugs awarded Commissioners National Priority vouchers.

18 Web Sites Warned About Illegal Botox Sales

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

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

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

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...