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Clinical Hold Lifted on Angelman Syndrome Study

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FDA removes a clinical hold against a GeneTx Biotherapeutics and Ultragenyx Pharmaceutical clinical trial of GTX-102, an investiga...

Workshop on Analgesic Clinical Trial Designs

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Federal Register notice: FDA announces a 10/13-14 public workshop entitled Analgesic Clinical Trial Designs, Extrapolation, and En...

Lilly Recalls 1 Lot of Glucagon Emergency Kit

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Eli Lilly recalls one lot of its Glucagon Emergency Kit for Low Blood Sugar after receiving a product complaint reporting that a v...

BMS Files 2 sBLAs for Opdivo/Yervoy

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FDA accepts for review two Bristol Myers Squibb supplemental BLAs for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) a...

Armstrong Medical Recalls Anesthesia Gas Cans

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Armstrong Medical recalls its Amsorb Plus Prefilled G-Can 1.0L due to reports that some canisters have difficulties with gas flow ...

Sunscreen OTC Monograph Proposed Order Available

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Federal Register notice: FDA makes availability of an over-the-counter monograph proposed order entitled Amending Over-the-Counter...

FDA Revokes 3 EUAs for No-longer-marketed Tests

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Federal Register notice: FDA revokes the emergency use authorizations for three Covid-19 tests after the companies requested such ...

FDA Generic Drugs Office Modifies Scientific Priorities

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The CDER Office of Generic Drugs revises its scientific priorities as part of its user fee performance goals through 2022.

FDA Approves Expanded Repatha Use

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FDA approves an Amgen supplemental BLA for Repatha (evolocumab) injection as an add-on treatment to diet alone or together with ce...

FDA Approves Tivdak for Cervical Cancer

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FDA grants Genmab and Seagen accelerated approval for their BLA for Tivdak (tisotumab vedotin-tftv), an antibody-drug conjugate fo...