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FDA Approves BioThrax to Prevent Anthrax Post-exposure

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FDA approves an Emergent BioDefense Operations Lansing BLA for a new indication for BioThrax (Anthrax Vaccine Adsorbed) preventin...

FDA Clears Entellus 510(k) for Pediatric Sinus Device

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FDA clears an Entellus Medical 510(k) for its XprESS Multi-Sinus Dilation System for treating maxillary sinuses in patients aged t...

Safety Alert on Intravascular Medical Device Coatings

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An FDA alert warns about intravascular medical devices made by various manufacturers that have the potential for their hydrophilic...

Brief Seeks Supremes Review of State Label Change Rules

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Wiley Rein files an amicus brief with the U.S. Supreme Court on behalf of the U.S. Chamber of Commerce that asks the high court to...

FDA Approves BMS Opdivo for Kidney Cancer

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FDA approves a Bristol-Myers Squibb NDA for Opdivo (nivolumab) to treat patients with advanced renal cell carcinoma in those who h...

FDA Approves Novartis Melanoma Drug Combination

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FDA grants regular approval to Novartis for its combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for treating patien...

Guidance on Sunscreen Active Ingredients

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Federal Register Notice: FDA releases a draft guidance: Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request.

Guidance on Sunscreen Advisory Committee Process

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Federal Register Notice: FDA releases a draft guidance: Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.

FDA Extends Clozapine REMS Certification Deadlines

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Due to ongoing implementation challenges with a new Clozapine Risk Evaluation and Mitigation Strategies program, FDA extends its 1...

Califf Writes on Importance of Patient Perspectives

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A JAMA Viewpoint article authored by FDA commissioner-nominee Robert Califf describes ongoing efforts at the agency on patient pre...