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Filspari sNDA Accepted for Rare Kidney Disease

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FDA accepts for review a Travere Therapeutics supplemental NDA for traditional approval of Filspari (sparsentan) for treating foca...

Fujirebio Diagnostics Gets Alzheimers Test Cleared

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FDA clears a Fujirebio Diagnostics 510(k) for the first in vitro diagnostic device that tests blood in diagnosing Alzheimers disea...

FDA Raises Issues on 4 Cancer Drugs at Panel

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FDA posts briefing documents outlining issues to be discussed during a two-day (5/20-21) Oncologic Drugs Advisory Committee meetin...

PharmaTher Ketamine NDA Review Extended by FDA

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FDA extends by two months its review of a PharmaTher NDA for Ketarx (ketamine) that is seeking anesthesia, sedation, pain, mental ...

Makary to Testify at 5/22 Budget Hearing

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FDA commissioner Marty Makary agrees to testify 5/22 at a Senate appropriations subcommittee hearing on the agencys fiscal year 20...

FDA Holds Inaugural Roundtable on Talc in Products

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FDA commissioner Marty Makary announces a 5/20 roundtable discussion on the safety and necessity of talc as an additive in food, d...

Amneals Brekiya Approved for Migraines

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FDA approves Amneals Brekiya, the only dihydrogotamine mesylate autoinjector available to treat migraine and cluster headaches in ...

FDA Accepts BioCryst Orladeyo NDA

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FDA accepts a BioCryst NDA for Orladeyo to be used in pediatric patients with hereditary angioedema.

Positive Data on Keytruda in Ovarian Cancer: Merck

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Merck's Keytruda meets a Phase 3 clinical trial primary endpoint of progression-free survival for treating patients with platinum-...

FDA OKs Incytes Zynyz for Anal Cancer

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FDA approves an Incyte supplemental BLA for Zynyz (retifanlimab-dlwr) in combination with carboplatin and paclitaxel for the first...