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FDAs Science Board to Meet

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Federal Register Notice: The Science Board to FDA will meet 9/15 to hear a report from the Science Looking Forward subcommittee.

Notice Corrected on Kidney Transplantation Workshop

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Federal Register Notice: FDA corrects an 8/3 Federal Register Notice on a public workshop on surrogate endpoints for clinical tria...

FDA Publishes Notice of Biosimilar Product Patent Infringement

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Federal Register Notice: FDA publishes notice that an applicant for a proposed biosimilar product notified the agency that a paten...

FDA OKs Product Under Rare Pediatric Voucher

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Federal Register Notice: FDA approves a Sanofi-Aventis NDA for Praluent, for which the applicant redeemed a rare pediatric disease...

FDA Approves Novartis Promacta for Pediatric Use

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FDA approves a Novartis supplemental NDA for Promacta (eltrombopag) to treat low blood platelet count in pediatric patients ages ...

FDA Extends Review of Alkermes Schizophrenia NDA

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FDA extends by a few weeks its review of an Alkermes NDA for Aristada (aripiprazole lauroxil) for treating schizophrenia.

FDA Breakthrough Status for Exelixis Cabozantinib

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FDA grants Exelixis, Inc. a breakthrough therapy designation for cabozantinib and its use in treating patients with advanced renal...

FTC Asks FDA to Reconsider Homeopathic Product Regs

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The Federal Trade Commission recommends that FDA reconsider the framework it uses to regulate homeopathic medications because it m...

Orphan Drug Status for Seres Therapeutics C.diff Drug

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FDA grants Seres Therapeutics an orphan drug designation for SER-109, an oral therapeutic currently in a Phase 2 clinical trial fo...

FDA Clears Dentcas 3D Denture Base Material

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FDA clears a 510(k) for the use of Dentcas new 3D printable material as a denture base.