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Janssen Files BLA for Stelara in Crohns Disease

[ Price : $8.95]

Janssen Biotech and Janssen-Cilag file a BLA seeking approval for Stelara (ustekinumab) for treating adult patients with moderate ...

FDA Approves Baxaltas Adynovate for Hemophilia

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FDA approves a Baxalta NDA for Adynovate (antihemophilic factor [recombinant], pegylated), an extended circulating half-life recom...

Panel to Hear Research Updates

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 1/14/16 to hear updates on the...

FDA Reviews Regulatory Issues for Gene Therapies

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FDA officials say clinical trial endpoints for investigational gene therapy products intended for treating cancer must be carefull...

Glades Drugs Recalls Compounded Multivitamins

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Glades Drugs recalls compounded multivitamin capsules containing high amounts of Vitamin D3 (cholecalciferol) after receiving seve...

FDA Approves BMS Enpliciti for Multiple Myeloma

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FDA approves a Bristol-Myers Squibb NDA for Empliciti (elotuzumab) for use in combination with two other therapies to treat multip...

Petition Denied Seeking Stricter Bioequivalence for Naprelan

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FDA denies an Almatica Pharma petition asking the agency to impose specific bioequivalence requirements on any ANDAs that referenc...

Beiersdorf Wants Nivea Drug Petition Denied

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Beiersdorf says FDA should deny a petition asking for enforcement action against the company for marketing a Nivea lotion as a cos...

Advisors Unimpressed by BioMarin Duchenne Trial

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Members of the FDA Peripheral and Central Nervous System Drugs Advisory Committee vote 15-2 that lack of efficacy in a BioMarin Ph...

Lyrica Trial Misses Endpoint

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Pfizer says that a Phase 3 trial of its Lyrica to treat adults with chronic post-traumatic peripheral neuropathic pain did not mee...