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Senate Health Committee Advances Califf Nomination

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The Senate Health, Education, Labor & Pensions Committee votes to move FDA commissioner nominee Robert Califfs nomination to an ev...

FDA Revises Janssen Vaccine Fact Sheets

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FDA revises fact sheets for the Janssen Covid-19 vaccine to discuss the risk of immune thrombocytopenia during the 42 days after v...

FDA Extends Expiration on Covid Tests in Florida

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FDA extends the expiration date on about one million unused Covid test kits in Florida.

Dental Issues with Some Buprenorphine Use: FDA

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FDA warns patients and providers about the potential for dental problems associated with dissolving buprenorphine products in the ...

Mitsubishi Tanabe NDA for Oral ALS Drug

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FDA accepts for priority review a Mitsubishi Tanabe Pharma America NDA for edaravone (MT-1186) for treating amyotrophic lateral sc...

CMS Questions FDA Aduhelm Approval: Analysis

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Washington University in St. Louis law professor Rachel Sachs says a CMS restricted coverage determination for Biogens Aduhelm add...

Novartis Seeking EUA for Covid Therapeutic

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Novartis and Molecular Partners say they plan to seek an FDA emergency use authorization after reporting results from the EMPATHY...

Skinny Label Allowed Faster Generic Entry: Study

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Harvard Medical School researchers say the use of skinny labeling in generic forms of Novartis Gleevec allowed the generics to ent...

FDA Accepts PharmaTher Ketamine IND for ALS

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FDA accepts an IND for a PharmaTher Phase 2 trial of ketamine to treat ALS.

Final Rule Revokes Older Human Tissue Regs

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Federal Register notice: FDA issues a final rule to revoke the regulations for human tissue intended for transplantation and human...